Journey to Better Health

NCT ID: NCT02938312

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-08-31

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).

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Weight Loss Only

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

Weight Loss Plus

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Monica L Baskin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

1U54CA153719

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F100708003

Identifier Type: -

Identifier Source: org_study_id