Journey to Better Health (JTBH)

Deep South Network for Cancer Control - Healthier Weight Among African American Women

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Weight Loss Only; Behavioral: Weight Loss Plus

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 Type: Interventional
• Enrollment (Actual): 409
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Behavioral: Weight Loss Only; Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
Experimental: 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	Behavioral: Weight Loss Plus; Participants attend in-person meetings as described above. This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measured weight (nearest kg)	baseline to 6-months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: F100708003; 1U54CA153719 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO