ObesityNCT02773069
The Church as a Bridge to Deliver Health Resources Via Telehealth
A study testing Church Bridge Project in people with Obesity and Diet, Food, and Nutrition, run by University of Southern Mississippi.
Trial summary
The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diet, Food, and Nutrition, Church
- What is being tested?
- Church Bridge Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jul 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >/=30
- Must have elementary aged child (5-11 years) in household
Who cannot join
- Any health condition where weight loss is contraindicated
- Complicated disease states (ie., advanced renal disease or heart failure)
About this study
Official title: The Church as a Bridge to Deliver Health Resources Via Telehealth to Alleviate Obesity and Chronic Disease Disparities in Rural African Americans of Mississippi
The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50 years of age) with families, the project will contribute to the long-term reduction of preventable chronic disease and related health care costs for the public.
- Conditions
- Obesity, Diet, Food, and Nutrition, Church, Healthcare Disparities, Minority Health, Mobile Health
- Being tested
- Church Bridge Project
- Medical subject headings
- Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Church Bridge ProjectBehavioural
Community-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss program | Experimental | Participants will attend a 12 session weight loss program accompanied by maintenance support delivered by a church. Program will include peer education, telenutrition counseling and mobile health feedback. Receives: Behavioral: Church Bridge Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight at six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Collaborators
- Southeast Mississippi Rural Health Initiative, MSU Extension- Stone County
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773069
- Sponsor's protocol ID
- 1R15MD010213-01
- Status last verified
- Oct 2017
- First submitted
- 10 May 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Church as a Bridge to Deliver Health Resources Via Telehealth to Alleviate Obesity and Chronic Disease Disparities in Rural African Americans of Mississippi
- ClinicalTrials.gov ID
- NCT02773069
- Acronym / sponsor ID
- 1R15MD010213-01
- Conditions
- Obesity, Diet, Food, and Nutrition, Church, Healthcare Disparities, Minority Health, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Collaborators
- Southeast Mississippi Rural Health Initiative, MSU Extension- Stone County
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 May 2016 (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.
The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50 years of age) with families, the project will contribute to the long-term reduction of preventable chronic disease and related health care costs for the public.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss program | Experimental | Behavioral: Church Bridge ProjectParticipants will attend a 12 session weight loss program accompanied by maintenance support delivered by a church. Program will include peer education, telenutrition counseling and mobile health feedback. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI >/=30
- Must have elementary aged child (5-11 years) in household
Key exclusion criteria (2 listed)
- Any health condition where weight loss is contraindicated
- Complicated disease states (ie., advanced renal disease or heart failure)
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 |
|---|---|---|
| Church Bridge ProjectCommunity-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders. | Behavioural | Weight loss program |
Primary outcome
Change in weight at six months
Time frame: 6 months
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 27 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Church Bridge Project in people with Obesity and Diet, Food, and Nutrition, run by University of Southern Mississippi.
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 2 inclusion and 2 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in weight at six months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2017.