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Journey to Better Health (JTBH)

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ClinicalTrials.gov Identifier: NCT02938312
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Monica L Baskin, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Weight Loss Only Behavioral: Weight Loss Plus Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Deep South Network for Cancer Control - Healthier Weight Among African American Women
Study Start Date : August 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Weight Loss Only
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)
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.

Experimental: Weight Loss Plus
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
Behavioral: 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.




Primary Outcome Measures :
  1. Weight [ Time Frame: baseline to 6-months ]
    Measured weight (nearest kg)


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938312


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)

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Responsible Party: Monica L Baskin, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02938312     History of Changes
Other Study ID Numbers: F100708003
1U54CA153719 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms