Journey to Better Health

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Behavioral: Weight Loss Plus; Behavioral: Weight Loss Only

• Registration Number: NCT02938312
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.

Detailed Description

Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.

Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.

Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).

Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 409

Inclusion Criteria

• African American female
• Live or work in target county
• BMI >= 25 kg/m2

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Exclusion Criteria

• Pregnant or planning to become pregnant in the next year
• Known major medical or psychological condition known to influence body weight
• Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
• Cardiovascular event in the preceding 12 months
• History of gastric bypass surgery
• History of psychiatric hospitalization in past 2 years
• History of substance abuse or eating disorder
• Any other condition by which a medical professional has suggested diet modification
• Physical activity and/or weight reduction would be contraindicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Loss Plus	Weight Loss Plus	Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity
Weight Loss Only	Weight Loss Only	24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls)

Primary Outcome Measures

Name	Time	Method
Weight	baseline to 6-months	Measured weight (nearest kg)

Secondary Outcome Measures

Name	Time	Method
Lipids	baseline to 6-months	Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
Social Support Healthy Eating and Exercise	baseline to 24-months	Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Self Efficacy for Healthy Eating and Exercise	baseline to 24-months	Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Weight	baseline to 24-months	Measured weight (nearest kg)
Perceived Stress Scale	baseline to 24-months	Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Waist Circumference	baseline to 6-months	Measured circumference (nearest cm)
Blood Pressure	baseline to 6-months	Measured blood pressure (mmHG) - systolic and diastolic
Social Support for Healthy Eating and Exercise	baseline to 12-months	Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Dietary Intake	baseline to 24-months	24 hour recall

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States