Daniel Fast as an Intervention for Weight Regain After Bariatric Surgery

The Daniel Fast as a Dietary and Spiritual Intervention for Women Experiencing Weight Regain after Bariatric Surgery

Table of Contents

Introduction with Research Question ………………………………………………………3

Research Design……………………………………………………………………………..5

Sampling plan….………………………………..……………………………………..……..6

Participants…………………………………………………………………………….……..7

Settings….…………………………………………….……………………………….……7

Recruitment………………………………………………………………………………7, 8

Protection of Human Subjects & Data Handling……………………………………………9

Instrumentation……………………………………………………………………………..10

Procedures…………………………………………………………………………………..11

Data Analysis………………………………………………………………………………14

Summary…………………………………………………………………………………..14

References………………………………………………………………………………….16

Appendix A………………………………………………………………………………..18

Appendix B………………………………………………………………………………..19

Appendix C………………………………………………………………………………..20

Appendix D………………………………………………………………………………..21

Appendix E…………………………………………………………………………………25

Revisiting the Purpose from Chapter I

The purpose of this study is to describe the perceptions of post-bariatric surgery women regarding the Daniel Fast (DF) as a spiritual and dietary intervention?”  The research question is “How do women that have regained significant weight after successful bariatric surgery perceive the DF as a spiritual and dietary intervention?” 

The aims are to:

1. Identify core processes related to the women’s perceptions of the DF as a spiritual and dietary intervention;
2. Identify spiritual and dietary strategies that were useful to the women for weight loss; and
3. Develop a grounded theory of the DF as a spiritual and dietary intervention for weight loss.

Chapter III

The proposed qualitative design and methodology is grounded theory (GT), specifically constructivist grounded theory (CGT) described by Charmaz (Higginbottom & Laurindsen, 2014; Streubert & Carpenter, 2011).  CGT is appropriate as it will facilitate capturing the women’s psychospiritual-social process of the DF.  As these women progress through the DF, they form and participate in support groups with facilitators of the DF and other women that are undertaking the DF in their church, work and home.  Many churches attempt to complete the DF at the beginning of the year (Hobbs, 2013), thus there are several individuals available to support one another with daily phone or internet contact.  This psychospiritual-social support and encouragement appears to help women comply with the dietary guidelines of the DF.  Healthcare and healthcare providers benefit from obtaining knowledge regarding mechanisms that help women to comply with dietary interventions.  Spirituality and spiritual dietary interventions that involves the social support of the church are understudied as mechanisms regarding compliance with dietary guidelines.  Moreover, there is no published knowledge of women’s perceptions of the DF as a spiritual and dietary intervention for weight loss.   

The theoretical influence concerns the mind-body-spirit construct of Jean Watson’s Philosophy and Science of Caring Theory (PSCT) (Watson, 2008).  This is a multidimensional construct stating that balance in each aspect (mind, body, and spirit) is the source of holistic health (Watson, 2008).  CGT examines multidimensional processes with unique stages through qualitative research methods such as interview, coding, theoretical sampling, memo writing, integrating abstractions and theory refining (Higginbottom & Laurindsen, 2014; Streubert & Carpenter, 2011).  CGT results with a theory that expresses the voice of the sample and illustrates complex issues beyond a basic process including beliefs and actions (Higginbottom & Lauridsen, 2014).

The Daniel Fast (DF) is a 21-day process of a spiritual fast that evolves daily and reduces dietary intake to little more than vegetables, nuts and water (Hobbs, 2013).  Spiritual fasting is done with the purpose of denying the body’s cravings to enhance the spiritual aspect of a person and their connection to God (Persynaki, Karras & Pichard, 2017).  The DF has not been studied for this population that has multidimensional issues.  Thus, any GT qualitative research design is appropriate to examine the process.  However, a CGT examination of the DF process will consider the complex issues, beliefs and actions mentioned above (Higginbottom & Lauridsen, 2014).  A uniform explanation that relates the codes and themes into a substantive theory is the outcome of the analysis of the data (Creswell, 2013; Streubert & Carpenter, 2011).  A substantive theory based on the voices of this study sample provides insight for healthcare providers caring for women experiencing weight regain after bariatric surgery.  Additionally, valuable interventions and framework will be added to the fight against obesity.

Selected Research Design

The CGT, Glaser and Strauss GT, and Strauss and Corbin GT are three versions of GT.  The methodology for Glaser and Strauss does not require a research question by does require the investigator to start without preconceived ideas (Streubert & Carpenter, 2011).  The Strauss and Corbin methodology requires a research question, investigator insight and transcription but may create forced analysis with coding and axial coding without a required theory (Streubert & Carpenter, 2011).  CGT described by Charmaz builds on the Glaser and Strauss GT and the Strauss and Corbin GT by adding an intuitive and subjective nature that accounts for the participant’s and the researcher’s points of view allowing for cocreation of the theory (Creswell, 2013; Higginbottom & Lauridsen, 2014; Streubert & Carpenter, 2011; Tappen, 2016).  Charmaz’s CGT compared to other GT designs was the best fit for this study in comparison to other qualitative designs.

All versions of GT have methods that use a cyclical system of collecting and analyzing data, thus the methodology is similar.  However, the theory extraction paradigm is where the differences lie between CGT and the other types of GT (Higginbottom & Lauridsen, 2014).  CGT has a world view that incorporates the complex interplay of the investigator’s reality and experiences, multiple underlying processes and views, and the sample’s voice heard through the investigator’s subjective interpretation (Higginbottom & Lauridsen, 2014).  The data is analyzed revealing aspects of the process that has covert situations, networks, and beliefs (Creswell, 2013).  A substantive theory is the co-creation of the investigator and the women in the sample and includes subtle abstractions of the process to capture the whole socio-spiritual experience (Creswell, 2013; Higginbottom & Lauridsen, 2014; Streubert & Carpenter, 2011; Tappen, 2016).

While other GT versions have the same unit of analysis, the singular focus process of these versions of GT would not consider the multidimensional process of the DF (Higginbottom & Laurindsen, 2014; Streubert & Carpenter, 2011).  This is critical for this DF process as it involves prayer and daily devotion, social support meetings, detailed meal preparation, and avoiding preservatives, sweeteners, and processed foods (Feola, 2010; Gregory, 2011).  CGT methodology fits well with the intentions of this study to examine the socio-spiritual process of the DF due to its unique focus and exploration of beliefs, values, feelings and complex realities (Creswell, 2013; Higginbottom & Lauridsen, 2014; Streubert & Carpenter, 2011; Tappen, 2016).

Explaining the process of using the DF as a spiritual and dietary intervention to address weight regain for women that have had bariatric surgery is the major aim of the study.  The DF is a complex all-inclusive process for this multidimensional condition.  Proper execution of the DF invades nearly every aspect of the day with waking in the am, the work day, social evening and bedtime at night.  There is likely a need to explore beliefs, values, feelings, complex realities, and diverse views of specific worlds such as the bariatric and severely obese populations ready to explore a spiritual intervention.  Capturing the essence of this specific DF experience is best done with the CGT qualitative research design.  CGT methods guide an investigator to explore and interpret data provided by an appropriate sample.  In this study, the psychosocial-spiritual processes of the DF experienced by post-bariatric women experiencing weight regain will be explored through CGT methods and result in a substantive theory.

Sampling Plan

Theoretical sampling guides the inclusion and exclusion criteria (Streubert & Carpenter, 2011; Tappen, 2016).  The appropriate sample contributes rich data for analysis to answer the research question stated above (Streubert & Carpenter, 2011; Tappen, 2016).  The inclusion criteria are women that had bariatric surgery of any type of gastric sleeve or gastric bypass over 5 years prior to the study and have regained at least 15% of their peak weight loss.  An all-female sample was chosen due to the overwhelming female population of patients having bariatric surgery (roughly 80%) (Farinholt, Carr, Chang & Ali, 2013; Sturm & Hattori, 2013).  The women’s age range is from 30-60 years old.  The women in the study must also possess a belief in God, have a willingness to participate fully in the DF, and be familiar with religious practices such as attending church.  Church membership is not required but preferred due to the comradery and social support that takes place during the fast if done as a group with a church.  The screening tool in Appendix A will include a question regarding the “name of your church”.

Exclusion criteria includes women that are atheist or have no spiritual interests, are pregnant, or have difficulty expressing themselves in English.  Revision surgery to their bariatric surgery or any surgical complications that required hospitalization excludes women from the study.  The women should refrain from appetite suppression medications during the 21 days of the DF but continue B 12 injections as meats are prohibited (Feola, 2010; Gregory, 2011).

The sample size desired is 20-50 women due to the CGT requirements (Higginbottom & Lauridsen, 2014; Streubert & Carpenter, 2011).  The exact number of women needed in the study is dependent on repetition or saturation occurring in the data and the themes that emerge (Streubert & Carpenter, 2011; Tappen, 2016).  This saturation signals that theoretical sampling has been achieved (Streubert & Carpenter, 2011).

The strategy for recruitment focuses on two weight loss clinics.  The PI will contact two weight loss clinic owners and medical directors to obtain permission for recruitment and/or the study to take place in their establishment.  The PI currently maintains a positive relationship with each clinic. Clinic one has a large private provider office shared by two MD’s and two mid-level providers (NP and PA), ten treatment rooms, a drug room, seven medical assistants (MA) and six administrative support staff.  Clinic two has five treatment room, one MD, a drug room and a lab, five MA’s and five support staff.  The clinics have a high volume of patients seeking physician directed weight loss.  These weight loss clinics have a high volume (>50/day) of female patients that have regained weight following bariatric surgery and would be interested in participating in the DF.  Based on access to a large group of eligible women, the PI should be able to recruit a sufficient sample size for the study.

The marketing plan for the study anchors on an effective flyer for advertising and the technique of snowballing.  Once the support letters and relevant Institutional Review Boards (IRB) approvals are obtained, the flyer will be placed in a stack at the front desk of both weight loss clinics for patients to read.  In addition, the flyer will be posted on the clinic’s websites.  The clinic medical assistants will be educated on the study and will disseminate the flyer to women who have had bariatric surgery and are interested in undertaking the DF.  The information on the flyer includes the purpose, the specific qualifying criteria, requirements of participants (60 to 90-minute interview), incentives (gift cards), and contact information for the PI.  Confidentiality of information and security of the interviews and data will also be addressed on the flyer.

In addition to direct recruitment, the methods of “snowballing” will also be employed (Streubert & Carpenter, 2011).  Women who participate in the study will be encouraged to advertise the study to other potentially eligible women within their social networks.  The weight loss and bariatric populations frequently network and share detailed information through blogs, exercise groups, church, family and phone.  The questions about rumors or facts concerning new weight loss methods or events in this community is often shared rapidly, thus snowballing with this population is likely to occur.

After an interested woman reaches out to the PI through the contact information, the PI will provide additional information and respond to any questions the woman may pose.  Thereafter, the PI may query the women to establish eligibility.  If the woman is eligible for participation, the PI will schedule a date and time and location to complete the consenting process and interview.  The proposed interview setting will be a private office at one of the weight loss clinics or in the home of the participating woman.  Informed consent forms will be signed at the time of the interview.

A record of the type of women participating in the study will be maintained. A grid will chart the type of procedure, demographics, spiritual and physical differences in Table 1 (Agazio, 2017).  Charting the women as they are considered for the study guides balancing the sample in terms of sample characteristics.  In addition, the grid allows the PI to assess the need for recruitment of specific populations if the majority of responding study participants have limited demographic characteristics (Agazio, 2017).

Table 1

Preliminary Grid for the Sample

Location	Weight Loss Clinic #1	Weight Loss Clinic #2
Procedure	Bypass	Bypass
	Sleeve	Sleeve
Demographic	Socioeconomic	Socioeconomic
	Education	Education
	Race	Race
Spiritual	Religion	Religion
	Membership	Membership
Physical	Current Weight	Current Weight
	Peak Weight Loss	Peak Weight Loss
	Percent Regained	Percent Regained

Note.  Adapted from “Week 5: Writing the sampling setting section 1 Ivyihl01 [Lecture notes] by Janice Agazio, 2017.

Human Subjects Protections

Permission to recruit and collect data from participating women will be obtained in the form of a letter of support/agreement from the two clinics and will be submitted for approval through the Institutional Review Board at the Catholic University of America.  The PI explains the study requirements, methods, and study aims to women interested in participating.  If screening indicates that the woman is eligible for participation in the study, an interview is scheduled.  Further detail is shared with the potential participant and an informed consent is signed with assurance of free will to end participation in the study at any time regardless of signed documents.

Interviews are recorded by audio using two recorders in case one fails during the interview.  Participating women will be required to journal daily highlights of their experience via cell phone voice memo or paper.  The voice recordings will be used only assist the women to fully answer the open-ended questions.  The voice memos may be recorded if they are heard during the interview but will remain on the personal cell phone of the participant.  Identification numbers will be assigned to the women to ensure confidentiality.  These numbers will correspond with notes, memos and data transcription.  Only the participant name will be collected as personal information.  The participant name will be linked with a study participant number, on a master list.  The consent forms with the participants’ names will be stored in a locked file cabinet maintained by the PI and separate from the participants’ research data.  All electronic data will be stored using password-protection and encryption.  Any computer used for storing data will not at any time be connected to a server.  All paper research records will be kept in a locked file maintained by the PI.  Only the PI will have access to any files that include subject identifying information. When the results of the study are printed or presented in conferences, no information will be given out that would identify any individual. Group data will be summarized in final report documents, and aspects of individual volunteer performance may be reported as well; however, participants’ names will never be published as a contributor of specific data points or as a participant in the study.

The risks are minimal and reasonable compared to the anticipated benefits from participating in the study.  The research may not benefit the participants personally, but findings of the study will provide understanding of how the Daniel Fast serves as a spiritual and dietary intervention for weight loss after post-bariatric weight regain.  Participants have the right to withdraw from this study at any time without penalty. If a participant decides to stop taking part in this study, he/she will be instructed to contact the PI as soon as possible.  The participant does not risks losing her right to medical care.  The decision to participate in this study is completely voluntary.

Instrumentation

The instruments used for this grounded theory study include a demographic data sheet, a question guide for the PI to conduct an unstructured interview, and a guide for the PI to conduct a focus group for validation of accurate core processes related to their experiences (Tappan, 2016).  The demographic data sheet found in Appendix A collects information such as age, race, education and income to describe the sample characteristics.

Interview Guide

The unstructured interview (Appendix E) is designed to explore the spiritual and dietary experience of the Daniel Fast for the participating women.  There are six categories that the PI anticipates the women will address.  Questions are carefully crafted to thoroughly explore each category to collect quality data (Tappen, 2016).  The categories are general responses, dietary changes or compliance, spiritual changes or compliance, social support or groups, physical changes, and weight loss result.  The open-ended questions should prompt in-depth responses that clearly descry be their experience.  The women are guided through the interview that lasts 60-90 minutes allowing for reflection and clarification when needed (Tappen, 2016).

Focus Group Guide

The focus group will be conducted after the individual interviews are completed.  A semi-structured interview beginning with focused open-ended questions and alternating specific questions will be conducted to facilitate communication of data (Tappen, 2016).  The questions will be based on the themes that emerge from the data.  The function of the group is to validate the results and explore how interactions effect responses (Tappen, 2016).  The meeting will take place in one of the clinics and conducted by the PI.  Follow-up meetings will be scheduled as needed to revisit issues or themes.

Procedures

A major concern regarding data collection interviews and data analysis is the Principal Investigator’s personal ideology and opinions based on experience.  Bracketing and reflexivity are procedures that will take place throughout the procedures of the study to improve rigor and remove bias (McGhee, Marland, & Atkinson, 2007).          

In both clinics, the providers, the medical assistants (MA’s) and the support staff will be briefed on the purpose, study procedures, and sample of the study.  The team will be instructed to disseminate a flyer (Appendix B) introducing the study to eligible women and instruct women to contact the PI whose information is provided on the flyer if they are interested in participating.  In addition, the flyer will be available in various patient areas such as the front desk and treatment rooms.  Once an interested woman contacts the PI and shares her phone number and email address, a newsletter (Appendix C) containing study details will be forwarded to the woman via email.  A phone call initiated by the PI will occur and with permission from the participating woman, the PI will screen the woman to determine eligibility for the study.  If the woman is eligible and interested in participating in the study, the PI describes the study procedures.  The PI provides instruction on the consenting process and the interview, the expected timeframe for both consenting process and the interview and indicates that the interview will be conducted at the clinic in a private room.  The PI schedules the interview on a date and time convenient for the woman and the PI.  The women will be briefed by the PI to allow ample time for the informed consent process along with the interview.  The woman will also be instructed that during the 21-day DF she is to keep a voice or written memo for each day completed and to buy the required book on Amazon prior to beginning the Daniel Fast.  The participant may refer to the voice or written memos during the interview to provide in-depth answers to the open-ended questions.

At the time scheduled for the interview, the participating woman will be greeted by the PI and escorted to the private room.  The PI will introduce the study and highlight that participation is voluntary and that refusal to participate will not result in any change in care.  In addition, the PI will obtain verbal permission for audio recording.  The PI will provide the woman a copy of the informed consent (Appendix D), which will be reviewed with the PI.  The woman will be allowed sufficient time to read the consent and to ask any questions.  Once the woman acknowledges adequate informed consent, she and the PI will sign the consent and the patient will be provided a copy of the signed consent.

For the interviews, two audio recorders will be used.  The PI will conduct the 60 to 90-minute interviews with an interview guide designed for the study (Appendix E).  Twenty-five-dollar ($25) gift cards from Amazon or Macy’s will be given to the women after the interview is completed as remuneration for participation.  The preferred method is the face-to-face interview, however in special cases a phone interview will be permitted.

The focus group will take place after the individual interviews are completed for verification of development of the core process and major themes.  The focus group will have six to eight women.  Every woman will be informed of the option to participate and request that each woman provide the PI with potential dates and times of availability for the focus groups.  Based on collation of the dates and times provided by the women, the PI will provide a listing of the most frequently cited available dates and times for the focus group.  Once six to eight women have identified that they are available on the same date and time, those women will be selected as the participants for the focus group.  Once the date and time, the participants, and the location of the focus group is established, the PI contact each of the selected participants and provide them the details regarding the focus group interviews. The group interview will be conducted at the same location; however, the time length will be 90-120 minutes.

Recruitment and interviews will continue until saturation of themes is achieved (Tappen, 2016).  The PI and the committee chair will decide together during ongoing analysis, the number of required participants.  The analysis is an evolving process that involves constant comparison and allows themes to emerge (Creswell, 2013; Tappen, 2016).

Data Analysis Plan

The methodology of grounded theory involves memoing private observations and differences and similarities in the data for future reference as codes emerge (Tappen, 2016).  The QSR NVIVO software will be uses to manage the memo’s and assist in describing and analyzing the data.  The transcribed interviews are reviewed by the PI and the committee.  The constant comparison and memo’s will guide the cycle of analysis of the emerging themes (Tappen, 2016).  The initial coding results in categories and will require using action verbs to denote the codes that will be entered into the QSR NVIVO software.  The focused coding follows and explores information to refine and validate the more general codes by comparing and questioning memos and data.  Then axial coding allows the data to be better synthesized by searching for relationships between categories and continuing the cycle of analysis until themes emerge, stabilize and are saturated.  The saturation of the codes will be determined as a team by the committee chair and the PI and is an ongoing process.  Concepts are then generated and examined for how they are related to form a hypothesis and visual framework, resulting in a substantive theory.  The goal is to obtain a substantive theory about the process of the Daniel Fast with saturated themes and well-developed explanations and discussions (Tappen, 2016).

Summary

The methodology described in this chapter is guided by GT and is designed to examine and understand a multidimensional process.  The purpose of the study is to describe the perceptions of post-bariatric women regarding the DF as a spiritual and dietary intervention.  Theoretical sampling with appropriate inclusion and exclusion criteria allows us to obtain rich data.  Analysis of this data guided by constructivism and GT methods will result in themes that relate to form hypothesis, a visual framework, and a substantive theory addressing the DF as a spiritual and dietary intervention for post-bariatric women experiencing weight regain.

References

Agazio, J. (2017). Week 5: Writing the sampling setting section 1 Ivyihl01 [Lecture notes].

Retrieved from: https://cua.hosted.panopto.com/Panopto/Pages/Viewer.aspx?id=b5f59240-c3ab-4413-948c-00bac6221d43

Creswell, J.W. (2013).  Qualitative inquiry & research design: Choosing among five approaches (3rd Ed.). Thousand Oaks, CA: Sage Publications, Inc.

Creswell, J.W. (2013). Research Design: Qualitative, quantitative, and mixed methods approaches (4th Ed).  Thousand Oaks, CA: Sage Publications.

Farinholt, G. N., Carr, A. D., Chang, E. J., & Ali, M. R. (2013). A call to arms: obese men with more severe comorbid disease and underutilization of bariatric operations. Surgical Endoscopy, 27(12), 4556-4563. doi:10.1007/s00464-013-3122-1

Feola, K. (2010). The ultimate guide to the Daniel fast.  Grand Rapids, MI: Zondervan.

Gregory S. (2011). The Daniel Fast: Feed your soul, strengthen your spirit and renew your body. New York:Tyndale House.

Higginbottom, G., & Lauridsen, E. I. (2014). The roots and development of constructivist grounded theory. Nurse Researcher, 21(5), 8-13. doi:10.7748/nr.21.5.8.e1208

Hobbs, Caitlin S. (2013). Three-dimensional nutrition: Exploring nourishment of spirit, mind, and body during a 28-day Daniel Fast at Southern Adventist University.  Senior Research Projects. Paper 163.  Retrieved from: http://knowledge.e.southern.edu/senior_research/163

McGhee, G., Marland, G.R., & Atkinson, J. (2007).  Grounded theory research: Literature reviewing and reflexivity. Journal of Advanced Nursing, 60(3), 334-342. doi: 1356-2648.2007.04436.x

Persynaki, A., Karras, S., & Pichard, C. (2017). Unraveling the metabolic health benefits of fasting related to religious beliefs: A narrative review.  Nutrition, 35, 14-20. doi: 10.1016/j.nut.2016.10.005.

Streubert, H.J. & Carpenter, D.R. (2011). Qualitative research in nursing: Advancing the     humanistic imperative (5th Ed). Philadelphia: Lippincott, Williams & Wilkins.

Sturm, R., & Hattori, A. (2013). Morbid obesity rates continue to rise rapidly in the United States. International Journal of Obesity, 37(6), 889-891.

Tappen, RM (2016).  Advanced Nursing Research: From theory to practice (2nd Ed.).  Sudbury, MA: Jones and Bartlett Learning.

Watson, J (2008). Nursing: The Philosophy and Science of Caring (rev. ed.), Boulder: University Press of Colorado.

Appendix A

Demographic Data Sheet

The demographic questionnaire is designed to collect information about the characteristics of the sample.

Code Number ____________                                                       Data Collection Date _________

1. What is your age?

2. What is your race? African, Black or Caribbean American, Caucasian, Hispanic, Asian, Other

3.  What is your marital status?  Single, Married, Separated, Widowed, Divorced, Living with a Partner

4. Do you speak English fluently? Which language do you speak most often?

5. What is your educational level? Completed some High School, Completed High School/GED, Some College, AA Degree, Bachelor’s Degree, Master’s Degree, Doctorate

6. What is your annual household income level?   Under 19,999, 20,000-39,999, 40,000-59,999, 60,000-79,999, 80,000-99,999, 100,000-149,999, over 150,000, unknown, refused

7. What type of bariatric surgery did you have? What year did you have your gastric bypass or sleeve?

8. What was your weight at the time of the surgery?

9. What was your lowest weight? Total weight lost?

10. How much did you gain back?

11. What is your current weight?

12.  What church do you attend?  Are you a member?

 

Appendix B

The flyer will be a large glossy card that measures five inches wide and seven inches long and will contain the purpose and qualifications of the study.  A preliminary draft of the flyer is illustrated below.

The Daniel Fast and Gastric Bypass Research Study

Are you a female between the ages of 30-60?          

Have you had gastric bypass or gastric sleeve over 5(five) years ago?

Have you regained weight you lost after the surgery?

Are you willing to conduct a 21-day Daniel Fast?

Will you talk about your experience in a one-hour interview?

Receive a $25 Amazon gift card for participating in a study exploring the process of the Daniel Fast as a dietary and spiritual intervention for women experiencing weight regain after bariatric surgery.  This study is approved by the Catholic University of America Institutional Review Board.  Contact the Principal Investigator at 49harrell@cua.edu or faye183@msn.com or 202-437-6464.

Appendix C

Thank you for your interest in the research study.  I am a doctoral student in the Online Doctor of Philosophy Program in Nursing at The Catholic University of America.  I am conducting research on the Daniel Fast.  Specifically, as way to help women having challenges with regaining their weight that they successfully lost after bariatric surgery.

I am recruiting volunteer participants for a qualitative study.  The qualifying criteria includes: 1. Be a female between the ages of 30 to 60 years old. 2. Have had gastric bypass or gastric sleeve at least 5 years prior to the interview. 3. Have regained at least 15% of the successful weight lost after having gastric bypass or gastric sleeve.  4. Speaks fluent English.  5. Be able/willing to buy a guidebook from Amazon for approximately $14 (Feola, Kristen, The Ultimate Guide to the Daniel Fast).  Participants will be asked to spend an hour in an individual interview and participate in a focus group with 5-7 other women at a prearranged location.  The interviews require a time commitment of approximately 60-90 minutes for individual interviews and 60 to 90 minutes for focus group sessions.  All participants will be offered a $25 gift card in appreciation for their participation upon completion of the interview(s).

The study has been approved by the Catholic University of America Office of Sponsored Programs and Research Services Committee on the Protection of Human Subjects.  Demographic information such as age, race, education and income level, marital status, and date and type of surgery will remain anonymous.  All interviews will be voice recorded then professionally transcribed to a protected written record.  Protecting the integrity and confidentiality of the subjects is of paramount importance.  Please contact me at faye183@msn.com or 202-437-6464 to proceed with participating in this research study described above and on the flyer.

Sincerely,

Faye Harrell, CRNP

Appendix D

The Catholic University of America Committee for the Protection of Human Subjects (CPHS)

Research Consent Form

Subject Name		Date

The Daniel Fast as a Dietary and Spiritual Intervention for Women Experiencing Weight Regain after Bariatric Surgery

  Title of Study

Faye R. Harrell, CRNP

  Principal Investigator

FWA00004459

INVITATION TO PARTICIPATE

You are being asked to participate in a research study that involves completing the Daniel Fast to address weight regain after bariatric surgery.  Participation in this study is voluntary and the ability to withdraw from the study is possible at any time.  There is no penalty or loss of benefits for withdrawal.  Please feel welcome to ask questions, read the entire consent, and ask the Principal Investigator (PI) any questions related to the study.  This informed consent form describes the research study; however, the study will be fully explained, verbally.  After gaining full understanding of the requirements, risks and benefits involved, you are able to make an informed decision to give consent to participate in this study.

PURPOSE

The purpose of this study is to describe the perceptions of women that have completed the Daniel Fast to address weight regain after gastric bypass or gastric sleeve surgery.

DESCRIPTION OF THE PROCEDURES

The participating women will purchase the Kristen Feola book, The Ultimate guide to the Daniel Fast at a cost of approximately 13 dollars.  This book specifies dietary restrictions and will serve as a guide for daily scripture and devotionals.  The Daniel Fast is conducted over 21 days.  There is support with recipe and scripture reading ideas.  For the study, the process includes daily audio journaling that can be done with phone memo’s that is standard on cell phones.

The PI will complete a 60-90 minute interview with you to discuss your dietary and spiritual experience with the Daniel Fast.  This interview will be in person or via telephone and will be recorded.

A face-to-face focus group to share results and verify findings after all the interviews are conducted.  The focus group will also be recorded and transcribed and will last approximately two hours.  Attendance is not required and is an extra and separate event.  Providing feedback and opinions is welcomed and will contribute to the findings of the study.

Findings of the study will provide understanding of how the Daniel Fast serves as a spiritual and dietary intervention for weight loss after post-bariatric surgery weight regain.

DISCOMFORTS AND RISKS

Discussing spiritual issues and sharing reflections may be uncomfortable, at times.  Openly discussing struggles with eating habits and struggles with weight control may become uncomfortable due to the personal nature of the interviews.  I anticipate that the risks are minimal and reasonable compared to the anticipated benefits from participating in the study.

A 21-day suspension of any appetite suppressant therapy which may require suspending or rescheduling one visit to the weight loss clinic.  However, all patients that receive B12 shots will have ample B12 for the 21 days.

CONFIDENTIALITY

Oversight for human subject protection by the Institutional Review Board of the Catholic University of America is in place to ensure confidentiality of your identity and interview information.  Anonymity is established with the use of code numbers that are linked to your personal information.  The code is stored separately from the personal information and information collected in the interview.

The results and information obtained by this study may be used in a dissertation, medical journals, and scientific meetings.  However, your name, code or identifying information will not appear in any published materials.  Your involvement in the study will not be released without written permission in a separate release of information.  Furthermore, confidentiality of medical records are protected by the Federal Privacy Act.

RISKS DURING PREGNANCY

Not applicable.

EXPECTED BENEFITS

The research may not benefit you personally, but findings of the study will provide understanding of how the Daniel Fast serves as a spiritual and dietary intervention for weight loss after post-bariatric surgery weight regain.

WITHDRAWAL FROM THE STUDY

Participating women should not feel compelled to participate in this study.  Any data collected will not be used at the wish of the participant.  You have the right to withdraw from this study at any time without penalty.  If you decide to stop taking part in this study, you should tell the PI as soon as possible. By leaving this study, you in no way risk losing your right to medical care.  The decision to participate in this study is completely voluntary.

COSTS AND PAYMENTS

Participation in the study requires no direct cost.  The purchase of the 13-dollar book to guide the process,

Kristen Feola book, The Ultimate guide to the Daniel Fast, is a cost.  Twenty-five dollar ($25) gift cards from Amazon will be remuneration for participation.

CONTACTS

If there are any questions, problems or concerns about the study or your participation, contact the Principal Investigator Faye R. Harrell, CRNP, faye183@msn.com, telephone 202-437-6464.

RESEARCH SUBJECT RIGHTS:  I have read or have had read to me all of the above.

 

                            has explained the study to me and answered all of my questions. I have been told of the risks or discomforts and possible benefits of the study.

I understand that I do not have to take part in this study, and my refusal to participate will involve no penalty or loss of rights to which I am entitled.  I may withdraw from this study at any time without penalty or loss of benefits to which I am entitled.

I understand that any information obtained as a result of my participation in this research study will be kept as confidential as legally possible.

The results of this study may be published, but my records will not be revealed unless required by law.

NOTE:

If I have any questions about the conduct of this study or my rights as a subject in this study, I have been told I can call The Catholic University of America, Office of Sponsored Programs 202-319-5218

I understand my rights as a research subject, and I voluntarily consent to participate in this study.  I understand what the study is about and how and why it is being done. I will receive a signed copy of this consent form.

Signature of Subject  Date
Signature of Subject’s Representative*   Date		Subject’s Representative (Print)
Signature of Witness Date		Witness (Print)
Signature of person obtaining consent** Date		Signature of Principal Investigator

  *Only required if subject is not competent.

**Only required if not investigator.

Appendix E

Unstructured Interview Guide

1. Please tell me about your experience with the 21-day Daniel Fast?
2. Describe your motivation for doing the fast?
3. Tell me about your diet?
4. Tell me about the spiritual component during the fast?
5. Where any other people or events helpful during this process?
6. What was helpful?
7. Where there any barriers or challenges?
8. What else would you like to tell me about this experience?

Spiritual Changes or Compliance

1. Tell me about the spiritual component of the fast.
2. Were there any revelations?
3. How did it help with the diet?

Social Support or Groups

1. How did the fast fit into your daily life?
2. Tell me how the Daniel Fast may have affected you physically or psychologically?
3. What were your goals for this Daniel Fast and did you achieve these goals?