Journey to Better Health

Weight Loss Clinical Trial

— JTBH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938312
• Other study ID #: F100708003
• Secondary ID: 1U54CA153719
• Status: Completed
• Phase: N/A
• First received: October 17, 2016
• Last updated: October 21, 2016
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Measured weight (nearest kg)	baseline to 6-months	No
Secondary	Waist Circumference	Measured circumference (nearest cm)	baseline to 6-months	No
Secondary	Blood Pressure	Measured blood pressure (mmHG) - systolic and diastolic	baseline to 6-months	No
Secondary	Lipids	Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio	baseline to 6-months	No
Secondary	Weight	Measured weight (nearest kg)	baseline to 12-months	No
Secondary	Weight	Measured weight (nearest kg)	baseline to 24-months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Self Efficacy for Healthy Eating and Exercise	Self-report	baseline to 12-months	No
Secondary	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	No
Secondary	Dietary Intake	24 hour recall	baseline to 6-months	No
Secondary	Dietary Intake	24 hour recall	baseline to 12-months	No
Secondary	Dietary Intake	24 hour recall	baseline to 24-months	No
Secondary	Perceived Stress Scale	Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.	baseline to 6-months	No
Secondary	Perceived Stress Scale	Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.	baseline to 12-months	No
Secondary	Perceived Stress Scale	Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.	baseline to 24-months	No