ObesityNCT04082702
Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
A study testing Faith-enhanced diabetes prevention program and Standard diabetes prevention program in people with Obesity and Pre-diabetes, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Obesity, Pre-diabetes
- What is being tested?
- Faith-enhanced diabetes prevention program and Standard diabetes prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2013to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as African-American
- Female
- 18 years of age or older
- Parishioner at enrolled church
- Overweight or obese
- Willingness to participate in a 10-month study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Obesity in African American Women Through Lifestyle Enhancement
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.
Read the detailed description
Reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (DPP), show reduced effectiveness in African American (AA) women. In addition to an attenuated response to lifestyle programs, AA women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. To address these disparities, enhancements to evidence-based lifestyle programs for AA women need to be developed and evaluated with culturally relevant and rigorous study designs. This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the DPP for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data (N=64 AA adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. 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 (Mean age =48.8 ±11.2; Mean BMI =36.7 ±8.4; 52% technical or high school) 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. This study provides essential data to guide enhancements to evidence-based lifestyle programs for AA women who are at high risk for chronic disease.
- Conditions
- Obesity, Pre-diabetes
- Being tested
- Faith-enhanced diabetes prevention program, Standard diabetes prevention program
- Keywords
- CBPR, DPP, African-American, Women, Obesity, Pre-diabetes
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith-enhanced diabetes prevention programBehavioural
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.
Standard diabetes prevention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard diabetes prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10-month
Secondary outcomes (20)
Fasting glucose
Fasting glucose was measured with the Cholestech LDX system
Measured: Baseline
Fasting glucose
Fasting glucose was measured with the Cholestech LDX system
Measured: 4-month
Glycated Hemoglobin A1c
Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Measured: Baseline
Glycated Hemoglobin A1c
Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Measured: 4-month
Low-density lipoprotein cholesterol (LDL)
LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
Measured: Baseline
Low-density lipoprotein cholesterol (LDL)
LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
Measured: 4-month
High-density lipoprotein cholesterol (HDL)
HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
Measured: Baseline
High-density lipoprotein cholesterol (HDL)
HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
Measured: 4-month
Blood pressure
Blood pressure was collected with an automated blood pressure device following a seated 5 min rest in a quiet area. Two measurements were taken following Eighth Joint National Committee protocols and averaged.
Measured: Baseline
Blood pressure
Blood pressure was collected with an automated blood pressure device following a seated 5 min rest in a quiet area. Two measurements were taken following Eighth Joint National Committee protocols and averaged.
Measured: 4-month
Blood pressure
Blood pressure was collected with an automated blood pressure device following a seated 5 min rest in a quiet area. Two measurements were taken following Eighth Joint National Committee protocols and averaged.
Measured: 10-month
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
Diet was measured with the Lower Mississippi Delta Nutrition Intervention Research Initiative (Delta NIRI) food frequency questionnaire. Data is scanned and analyzed by Northeastern University's Dietary Assessment Center. Total energy, fat, sodium, and other dietary components were estimated from the questionnaire.
Desired total energy (Kcal) (range: 500 to 10,000) intake is defined as 2000 Kcal or less.
Desired fat (gram) (range: 10 to 500) intake is defined as 77 gram or less. Desired sodium (milligram) (range: 100 to 20,000) intake is defined as 2300 milligram or less.
Measured: Baseline
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
Diet was measured with the Lower Mississippi Delta Nutrition Intervention Research Initiative (Delta NIRI) food frequency questionnaire. Data is scanned and analyzed by Northeastern University's Dietary Assessment Center. Total energy, fat, sodium, and other dietary components were estimated from the questionnaire.
Desired total energy (Kcal) (range: 500 to 10,000) intake is defined as 2000 Kcal or less.
Desired fat (gram) (range: 10 to 500) intake is defined as 77 gram or less. Desired sodium (milligram) (range: 100 to 20,000) intake is defined as 2300 milligram or less.
Measured: 4-month
Physical activity: Total number of active minutes per week
Physical activity was measured by self-report with the Past Week Modifiable Physical Activity Questionnaire. A total of all physical activity minutes was calculated from the questionnaire.
Desired level of physical activity is defined as 150 minutes or more per week.
Measured: Baseline
Physical activity: Total number of active minutes per week
Physical activity was measured by self-report with the Past Week Modifiable Physical Activity Questionnaire. A total of all physical activity minutes was calculated from the questionnaire.
Desired level of physical activity is defined as 150 minutes or more per week.
Measured: 4-month
Physical activity
Physical activity was measured by self-report with the Past Week Modifiable Physical Activity Questionnaire. A total of all physical activity minutes was calculated from the questionnaire.
Desired level of physical activity is defined as 150 minutes or more per week.
Measured: 10-month
Estradiol (pg/mL)
Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Measured: Baseline
Estradiol (pg/mL)
Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Measured: 4-month
Cortisol (ng/mL)
Fasting morning saliva sent to a laboratory to assay
Measured: Baseline
Cortisol (ng/mL)
Fasting morning saliva sent to a laboratory to assay
Measured: 4-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start22 Feb 2013
- Primary completion1 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Responsible party
- Sponsor
- Investigators
- Heather Kitzman, PhD, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082702
- Sponsor's protocol ID
- P20MD006882-2
- Other IDs
- P20MD006882
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact site contact person
Publications
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.
PubMed 28807739Tan 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.
PubMed 29166248Kitzman 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.
PubMed 32945175Mamun 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.
PubMed 32605881
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity in African American Women Through Lifestyle Enhancement
- ClinicalTrials.gov ID
- NCT04082702
- Acronym / sponsor ID
- P20MD006882-2
- Conditions
- Obesity, Pre-diabetes
- Keywords
- CBPR, DPP, African-American, Women, Obesity, Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (DPP), show reduced effectiveness in African American (AA) women. In addition to an attenuated response to lifestyle programs, AA women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. To address these disparities, enhancements to evidence-based lifestyle programs for AA women need to be developed and evaluated with culturally relevant and rigorous study designs. This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the DPP for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data (N=64 AA adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. 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 (Mean age =48.8 ±11.2; Mean BMI =36.7 ±8.4; 52% technical or high school) 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. This study provides essential data to guide enhancements to evidence-based lifestyle programs for AA women who are at high risk for chronic disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Faith-enhanced DPP | Experimental | Behavioral: Faith-enhanced diabetes prevention programA total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components. |
| Standard DPP | Active comparator | Behavioral: Standard diabetes prevention programA total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identify as African-American
- Female
- 18 years of age or older
- Parishioner at enrolled church
- Overweight or obese
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faith-enhanced diabetes prevention programThe 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. | Behavioural | Faith-enhanced DPP |
| Standard diabetes prevention programThe 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. | Behavioural | Standard DPP |
Primary outcome
Body weight
Time frame: Baseline
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).
Body weight
Time frame: 4-month
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).
Body weight
Time frame: 10-month
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).
Waist circumference: Number of participants above the recommended level
Time frame: Baseline
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.
Waist circumference: Number of participants above the recommended level
Time frame: 4-month
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.
Waist circumference: Number of participants above the recommended level
Time frame: 10-month
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.
20 secondary outcomes
Fasting glucose
Time frame: Baseline
Fasting glucose
Time frame: 4-month
Glycated Hemoglobin A1c
Time frame: Baseline
Glycated Hemoglobin A1c
Time frame: 4-month
Low-density lipoprotein cholesterol (LDL)
Time frame: Baseline
Low-density lipoprotein cholesterol (LDL)
Time frame: 4-month
High-density lipoprotein cholesterol (HDL)
Time frame: Baseline
High-density lipoprotein cholesterol (HDL)
Time frame: 4-month
Blood pressure
Time frame: Baseline
Blood pressure
Time frame: 4-month
Blood pressure
Time frame: 10-month
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
Time frame: Baseline
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
Time frame: 4-month
Physical activity: Total number of active minutes per week
Time frame: Baseline
Physical activity: Total number of active minutes per week
Time frame: 4-month
Physical activity
Time frame: 10-month
Estradiol (pg/mL)
Time frame: Baseline
Estradiol (pg/mL)
Time frame: 4-month
Cortisol (ng/mL)
Time frame: Baseline
Cortisol (ng/mL)
Time frame: 4-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Background: PubMed 28807739Kitzman 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.
- Background: PubMed 29166248Tan 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.
- Derived from this study: PubMed 32945175Kitzman 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.
- Derived from this study: PubMed 32605881Mamun 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.
- Individual participant dataSharing planned: Yes. Contact site contact person
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Kitzman, PhD principal investigator
Baylor Scott and White Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faith-enhanced diabetes prevention program and Standard diabetes prevention program in people with Obesity and Pre-diabetes, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082702, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.