Skip to main content
OpenTrials
Completed

NCT Number: NCT02938312

Journey to Better Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss Only

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

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.

Primary outcomes

  1. Weight

    Time frame: baseline to 6-months

    Measured weight (nearest kg)

Secondary outcomes

  1. Waist Circumference

    Time frame: baseline to 6-months

    Measured circumference (nearest cm)

  2. Blood Pressure

    Time frame: baseline to 6-months

    Measured blood pressure (mmHG) - systolic and diastolic

  3. Lipids

    Time frame: baseline to 6-months

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

  4. Weight

    Time frame: baseline to 12-months

    Measured weight (nearest kg)

  5. Weight

    Time frame: baseline to 24-months

    Measured weight (nearest kg)

  6. Social Support for Healthy Eating and Exercise

    Time frame: baseline to 6-months

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

  7. Social Support for Healthy Eating and Exercise

    Time frame: baseline to 12-months

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

  8. Social Support Healthy Eating and Exercise

    Time frame: baseline to 24-months

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

  9. Self Efficacy for Healthy Eating and Exercise

    Time frame: baseline to 6-months

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

  10. Self Efficacy for Healthy Eating and Exercise

    Time frame: baseline to 12-months

    Self-report

  11. Self Efficacy for Healthy Eating and Exercise

    Time frame: baseline to 24-months

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

  12. Dietary Intake

    Time frame: baseline to 6-months

    24 hour recall

  13. Dietary Intake

    Time frame: baseline to 12-months

    24 hour recall

  14. Dietary Intake

    Time frame: baseline to 24-months

    24 hour recall

  15. Perceived Stress Scale

    Time frame: baseline to 6-months

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

  16. Perceived Stress Scale

    Time frame: baseline to 12-months

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

  17. Perceived Stress Scale

    Time frame: baseline to 24-months

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: JTBH

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 19, 2016
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.