Clinical trial NCT02938312: Journey to Better Health
Official title: Deep South Network for Cancer Control - Healthier Weight Among African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-10-19
Enrollment: 409
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Weight
timeFrame: baseline to 6-months
Secondary outcomes:
measure: Waist Circumference
timeFrame: baseline to 6-months
measure: Blood Pressure
timeFrame: baseline to 6-months
measure: Lipids
timeFrame: baseline to 6-months
measure: Weight
timeFrame: baseline to 12-months
measure: Weight
timeFrame: baseline to 24-months
measure: Social Support for Healthy Eating and Exercise
timeFrame: baseline to 6-months
measure: Social Support for Healthy Eating and Exercise
timeFrame: baseline to 12-months
measure: Social Support Healthy Eating and Exercise
timeFrame: baseline to 24-months
measure: Self Efficacy for Healthy Eating and Exercise
timeFrame: baseline to 6-months
measure: Self Efficacy for Healthy Eating and Exercise
timeFrame: baseline to 12-months
measure: Self Efficacy for Healthy Eating and Exercise
timeFrame: baseline to 24-months
measure: Dietary Intake
timeFrame: baseline to 6-months
measure: Dietary Intake
timeFrame: baseline to 12-months
measure: Dietary Intake
timeFrame: baseline to 24-months
measure: Perceived Stress Scale
timeFrame: baseline to 6-months
measure: Perceived Stress Scale
timeFrame: baseline to 12-months
measure: Perceived Stress Scale
timeFrame: baseline to 24-months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: