Symptoms and General Pathology

All Conditions

Weight Loss

Body Weight

Body Weight Changes

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)

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

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 Only

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.

Weight Loss Plus

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.

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).

Journey to Better Health

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

Measured blood pressure (mmHG) - systolic and diastolic

Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio

Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.

Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.

Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.

National Cancer Institute (NCI)

University of Alabama at Birmingham

Principal Investigator

Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (\~5-10% of baseline weight).

Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (\~5-10% of baseline weight) plus community-level strategies to support healthy weight. Strategies are based on CDC's recommended community strategies and are developed by local contractors. They include expanded farmers markets/gardens, improvement to walking trails, etc.

Educational materials and optional participation in community-wide cancer awareness activities.

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)

Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.

Control

This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.

This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).

Promoting Weight-Loss in African American Cancer Survivors in the Deep South

Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL)

self report measure of social support (family, friend) in performing diet and exercise behaviors

self report measure of confidence in performing diet and exercise behaviors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Journey to Better Health	NCT02938312	Weight Loss	Weight Loss Onl... Weight Loss Plu...	30 Years - 70 Years	University of Alabama at Birmingham
Promoting Weight-Loss in African American Cancer Survivors in the Deep South	NCT03150381	Weight Loss Cancer	Weight Loss Onl... Weight Loss Plu... Control	19 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for weight loss only