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Journey to Better Health (JTBH)

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Only
Weight Loss Plus
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight Loss Only

Weight Loss Plus

Arm Description

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

Outcomes

Primary Outcome Measures

Weight
Measured weight (nearest kg)

Secondary Outcome Measures

Waist Circumference
Measured circumference (nearest cm)
Blood Pressure
Measured blood pressure (mmHG) - systolic and diastolic
Lipids
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
Weight
Measured weight (nearest kg)
Weight
Measured weight (nearest kg)
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.
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.
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.
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.
Self Efficacy for Healthy Eating and Exercise
Self-report
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.
Dietary Intake
24 hour recall
Dietary Intake
24 hour recall
Dietary Intake
24 hour recall
Perceived Stress Scale
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Perceived Stress Scale
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Perceived Stress Scale
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.

Full Information

First Posted
October 17, 2016
Last Updated
October 21, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02938312
Brief Title
Journey to Better Health
Acronym
JTBH
Official Title
Deep South Network for Cancer Control - Healthier Weight Among African American Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss Only
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Weight Loss Plus
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Only
Intervention Description
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
Intervention Name(s)
Weight Loss Plus
Intervention Description
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 Outcome Measure Information:
Title
Weight
Description
Measured weight (nearest kg)
Time Frame
baseline to 6-months
Secondary Outcome Measure Information:
Title
Waist Circumference
Description
Measured circumference (nearest cm)
Time Frame
baseline to 6-months
Title
Blood Pressure
Description
Measured blood pressure (mmHG) - systolic and diastolic
Time Frame
baseline to 6-months
Title
Lipids
Description
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
Time Frame
baseline to 6-months
Title
Weight
Description
Measured weight (nearest kg)
Time Frame
baseline to 12-months
Title
Weight
Description
Measured weight (nearest kg)
Time Frame
baseline to 24-months
Title
Social Support for Healthy Eating and Exercise
Description
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Time Frame
baseline to 6-months
Title
Social Support for Healthy Eating and Exercise
Description
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Time Frame
baseline to 12-months
Title
Social Support Healthy Eating and Exercise
Description
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated.
Time Frame
baseline to 24-months
Title
Self Efficacy for Healthy Eating and Exercise
Description
Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Time Frame
baseline to 6-months
Title
Self Efficacy for Healthy Eating and Exercise
Description
Self-report
Time Frame
baseline to 12-months
Title
Self Efficacy for Healthy Eating and Exercise
Description
Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated.
Time Frame
baseline to 24-months
Title
Dietary Intake
Description
24 hour recall
Time Frame
baseline to 6-months
Title
Dietary Intake
Description
24 hour recall
Time Frame
baseline to 12-months
Title
Dietary Intake
Description
24 hour recall
Time Frame
baseline to 24-months
Title
Perceived Stress Scale
Description
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Time Frame
baseline to 6-months
Title
Perceived Stress Scale
Description
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Time Frame
baseline to 12-months
Title
Perceived Stress Scale
Description
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
Time Frame
baseline to 24-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Journey to Better Health

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