NCT03614338

Brief Summary

African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

July 30, 2018

Last Update Submit

August 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight

    Change from baseline using objectively measured body weight

    3 months

Secondary Outcomes (5)

  • Blood pressure

    3 months

  • Physical activity

    3 months

  • Weight loss strategies

    3 months

  • Weight

    6 months

  • HbA1c

    3 months

Other Outcomes (2)

  • Program satisfaction

    3 months

  • Program engagement

    3 months

Study Arms (1)

Core Participants Weight Loss Program

EXPERIMENTAL

Small changes weight loss program

Behavioral: Small changes weight loss program

Interventions

This intervention uses a "small-changes" approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions.

Core Participants Weight Loss Program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25-45 kg/m2
  • Age 18-75
  • Attend one of the West Side partnership churches at least 2 times per month
  • Able to attend in-person meetings
  • Willing to share their experiences on the West Side ALIVE Facebook page

You may not qualify if:

  • Blood pressure \> 170/90 (self-report or during the WSA screening)
  • Diabetes treated with insulin
  • History of cancer within the past 5 years
  • Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

January 3, 2019

Primary Completion

May 8, 2019

Study Completion

August 15, 2019

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations