Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

NCT04082702 | Completed DMC

• 2 other identifiers: P20MD006882-2P20MD006882
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the diabetes prevention program (DPP) for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 after collection of objective eligibility measures. A prospective, randomized, nested by church, design was used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up.

Conditions

Obesity; Pre-diabetes

Keywords

CBPR; DPP; African-American; Women; Obesity; Pre-diabetes

Outcome Measures

Primary Outcomes (6)

• Body weight

  Weight (lbs) was collected with a digital scale in light clothing with shoes removed. Weight was collected twice and the average was computed. Height was also measured using the same protocol to calculate the BMI (body-mass index).

  Baseline

• Body weight

  Weight (lbs) was collected with a digital scale in light clothing with shoes removed. Weight was collected twice and the average was computed. Height was also measured using the same protocol to calculate the BMI (body-mass index).

  4-month

• Body weight

  Weight (lbs) was collected with a digital scale in light clothing with shoes removed. Weight was collected twice and the average was computed. Height was also measured using the same protocol to calculate the BMI (body-mass index).

  10-month

• Waist circumference: Number of participants above the recommended level

  Waist circumference was taken at the top of the pelvis (e.g., above the uppermost lateral border of the right ilium) with a measuring tape twice and averaged.

  Baseline

• Waist circumference: Number of participants above the recommended level

  Waist circumference was taken at the top of the pelvis (e.g., above the uppermost lateral border of the right ilium) with a measuring tape twice and averaged.

  4-month

• Waist circumference: Number of participants above the recommended level

  Waist circumference was taken at the top of the pelvis (e.g., above the uppermost lateral border of the right ilium) with a measuring tape twice and averaged.

  10-month

Secondary Outcomes (20)

• Fasting glucose

  Baseline

• Fasting glucose

  4-month

• Glycated Hemoglobin A1c

  Baseline

• Glycated Hemoglobin A1c

  4-month

• Low-density lipoprotein cholesterol (LDL)

  Baseline

Study Arms (2)

Faith-enhanced DPP

EXPERIMENTAL

A total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components.

Behavioral: Faith-enhanced diabetes prevention program

Standard DPP

ACTIVE COMPARATOR

A total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings.

Behavioral: Standard diabetes prevention program

Interventions

Faith-enhanced diabetes prevention program BEHAVIORAL

The faith-enhanced curriculum was faith-based and developed using CBPR approaches. The Faith-DPP condition included delivery of the DPP. The group intervention was delivered by one to two trained peers from the church and consisted of 16 weekly group meetings followed by 6 bi-monthly or monthly maintenance sessions. The faith enhanced curriculum included five strategies: 1) a mini sermon (\~15 min in length) delivered by a pastor (head pastors were required to deliver at least one per month), first lady, or church leader (pastor associate, deacon, elder, etc.), 2) a memory verse, 3) in class or take-home faith activity (application of faith principles), 4) promises to remember, and 5) scripture and prayer integrated into participant curriculum and facilitator materials. These five faith enhancements were developed by the CAB to enhance the DPP's weekly learning objectives, which resulted in faith components specifically linked to each week of DPP content.

Faith-enhanced DPP

Standard diabetes prevention program BEHAVIORAL

The S-DPP condition was faith-placed, a secular program (the DPP) held at an faith-based organization. This condition received the same diabetes prevention program (DPP) as the Faith-DPP, but did not receive any faith enhancements or pastor involvement.

Standard DPP

Eligibility Criteria

• Age: 18 Years - 120 Years
• Gender Eligibility Details: Only female participants were eligible to enroll in this study due to their higher risk for obesity and diabetes.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as African-American
• Female
• years of age or older
• Parishioner at enrolled church
• Overweight or obese
• Willingness to participate in a 10-month study.

You may not qualify if:

• Currently attending a weight loss program
• Diagnosed with diabetes
• Medical condition that interfered with physical activity or dietary changes
• Plans to move in the next 10 months.

Sponsors & Collaborators

• Baylor Research Institute: lead
• University of North Texas Health Science Center: collaborator

Study Sites (1)

UNT Health Science Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (4)

• Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.

  PMID: 28807739 BACKGROUND

• Tan M, Mamun A, Kitzman H, Mandapati SR, Dodgen L. Neighborhood Disadvantage and Allostatic Load in African American Women at Risk for Obesity-Related Diseases. Prev Chronic Dis. 2017 Nov 22;14:E119. doi: 10.5888/pcd14.170143.

  PMID: 29166248 BACKGROUND

• Kitzman H, Mamun A, Dodgen L, Slater D, King G, King A, Slater JL, DeHaven M. Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women. Am J Health Promot. 2021 Feb;35(2):202-213. doi: 10.1177/0890117120958545. Epub 2020 Sep 18.

  PMID: 32945175 DERIVED

• Mamun A, Kitzman H, Dodgen L. Reducing metabolic syndrome through a community-based lifestyle intervention in African American women. Nutr Metab Cardiovasc Dis. 2020 Sep 24;30(10):1785-1794. doi: 10.1016/j.numecd.2020.06.005. Epub 2020 Jun 12.

  PMID: 32605881 DERIVED

MeSH Terms

Conditions

Obesity; Glucose Intolerance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Heather Kitzman, PhD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel involved in delivering interventions were not allowed to facilitate the outcome measures. Project coordinator, key personnel, and trained volunteers (which included graduate students) collected all the data elements. Statisticians and data coordinators were blinded of intervention group assignments of the participants until the end of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a prospective, 2-group, randomized nested (by church) design with eleven congregations, comparing a healthy weight management program with a pastor/church leader component (Intervention) to a healthy weight management program without a pastor/church component (Control). Focus groups were conducted with a sample of 64 participants for understanding needs, perspectives and barriers to healthy weight management. A total of 221 overweight and obese female participants from about 11 churches (approximately 25-30 individuals per church) were recruited and participated in this study following the protocols. The DPP Curriculum includes an intervention phase (approximately weekly for 4 months) and maintenance phase (once or twice a month for 6 months). Faith components (handouts and mini-sermon) are only used by the treatment (intervention) group through both the intervention and maintenance phase.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 9, 2019
• Study Start: February 22, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 31, 2017
• Last Updated: December 11, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)