DiabetesNCT01730196
Lifestyle Change to Prevent Diabetes Via African-American Churches
A study testing Fit Body and Soul and Wellness Education in people with Diabetes and Weight Loss, run by Augusta University at 1 site in United States.
Trial summary
Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Weight Loss
- What is being tested?
- Fit Body and Soul and Wellness Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2013
- 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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-described African American
- BMI ≥25kg/m2
- Planning to remain within the community for 1 year
- Non-diabetic
Who cannot join
- Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
- HIV/AIDS
- Active tuberculosis
- Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
- Stroke within the past 6 months
- Cirrhosis of the liver
Show all 17Show fewer
- Currently pregnant or planning pregnancy within the study period
- Gastric weight-loss surgery
- Weight loss > 10% in past three months for any reason other than childbirth
- Anti-diabetic medications
- Prescription weight- loss medications
- Anti-neoplastic agents
- Anti-psychotic agents that have gluco-corticoid effect
- Oral corticosteroid use >6 weeks
- Unwilling or unable to give informed consent
- Unable to communicate with the church team or research group
- Participation in another research study that would interfere with FBAS
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
Official title: Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention.
- Conditions
- Diabetes, Weight Loss
- Being tested
- Fit Body and Soul, Wellness Education
- Medical subject headings
- Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit Body and SoulBehavioural
Wellness EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Fit Body and Soul | Experimental | Faith-based adaptation of the Group Life Style Program Receives: Behavioral: Fit Body and Soul |
| Wellness education | Active comparator | A health education program developed from the list of topics provided by the Centers for Disease Control and Prevention (CDC) Guide to Community Prevention Services Receives: Behavioral: Wellness Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: 12-weeks post intervention
Secondary outcomes (5)
Fasting plasma glucose
Measured: 12 week post intervention
physical activity level
Measured: 12 week post-intervention
quality of life measures
Measured: 12 week post-intervention
cost-effectiveness
Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®
Measured: 12 week post-intervetnion
hemoglobin A1C
Measured: 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startSep 2009
- Primary completionApr 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Sattin, Augusta University
- Investigators
- Richard W Sattin, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730196
- Sponsor's protocol ID
- R18DK082401
- Status last verified
- Apr 2014
- First submitted
- 15 Nov 2012
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
PubMed 30273708Sattin RW, Williams LB, Dias J, Garvin JT, Marion L, Joshua TV, Kriska A, Kramer MK, Narayan KM. Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes Among African-Americans. J Community Health. 2016 Feb;41(1):87-96. doi: 10.1007/s10900-015-0071-8.
PubMed 26215167
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
- ClinicalTrials.gov ID
- NCT01730196
- Acronym / sponsor ID
- R18DK082401
- Conditions
- Diabetes, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Nov 2012 (estimated)
- 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.
Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fit Body and Soul | Experimental | Behavioral: Fit Body and SoulFaith-based adaptation of the Group Life Style Program |
| Wellness education | Active comparator | Behavioral: Wellness EducationA health education program developed from the list of topics provided by the Centers for Disease Control and Prevention (CDC) Guide to Community Prevention Services |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Self-described African American
- BMI ≥25kg/m2
- Planning to remain within the community for 1 year
- Non-diabetic
Key exclusion criteria (17 listed)
- Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
- HIV/AIDS
- Active tuberculosis
- Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
- Stroke within the past 6 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 |
|---|---|---|
| Fit Body and Soul | Behavioural | Fit Body and Soul |
| Wellness Education | Behavioural | Wellness education |
Primary outcome
Weight change
Time frame: 12-weeks post intervention
5 secondary outcomes
Fasting plasma glucose
Time frame: 12 week post intervention
physical activity level
Time frame: 12 week post-intervention
quality of life measures
Time frame: 12 week post-intervention
cost-effectiveness
Time frame: 12 week post-intervetnion
hemoglobin A1C
Time frame: 12 week intervention
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 9 Apr 2014.
- Derived from this study: PubMed 30273708Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
- Derived from this study: PubMed 26215167Sattin RW, Williams LB, Dias J, Garvin JT, Marion L, Joshua TV, Kriska A, Kramer MK, Narayan KM. Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes Among African-Americans. J Community Health. 2016 Feb;41(1):87-96. doi: 10.1007/s10900-015-0071-8.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Richard W Sattin, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit Body and Soul and Wellness Education in people with Diabetes and Weight Loss, run by Augusta University 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 4 inclusion and 17 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 9 Apr 2014. 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?
Weight change (time frame: 12-weeks post intervention). 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 NCT01730196, which also lists 2 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 9 Apr 2014.