NCT02773069

Brief 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, 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

May 10, 2016

Last Update Submit

October 25, 2017

Conditions

ObesityDiet, Food, and NutritionChurchHealthcare DisparitiesMinority HealthMobile HealthTelehealthCommunity-based Participatory ResearchPrimary Health CareWeight Loss ProgramsHealth Behavior

Outcome Measures

Primary Outcomes (1)

  • Change in weight at six months

    6 months

Study Arms (1)

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.

Behavioral: Church Bridge Project

Interventions

Church Bridge ProjectBEHAVIORAL

Community-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders.

Weight loss program

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>/=30
  • Must have elementary aged child (5-11 years) in household

You may not qualify if:

  • Any health condition where weight loss is contraindicated
  • Complicated disease states (ie., advanced renal disease or heart failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 16, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10