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Sisters in Health: A Weight Loss Study for African American Women

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard Weight Loss Intervention
Physical Activity Enhanced Weight Loss Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 21-65 years old
  • Ability to read, write, and speak English

    • Female gender
    • African American/Black/African/Afro-Caribbean race (self-identified)
    • BMI 25-45 (> 45 may have greater risks while participating)
    • Meets criteria for low active (defined as <3 days/week of at most 20 min. of PA/day) assessed by X
    • Willingness to be randomized
    • Willingness to participate for 6 months, including attending face-to-face sessions & outside of session tasks
    • Access to a computer reliable internet access
    • Willingness to use an app for diet and physical activity monitoring
    • Regularly used email address
    • Not planning to relocate
    • Able to attend group sessions on scheduled day

Exclusion Criteria:

  • Recently lost weight, 5-10% in last 6 months
  • Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities
  • Pregnant or planning to become pregnant
  • Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure)
  • Type 2 diabetes being treated with insulin
  • Major psychological disorder
  • History of diagnosed eating disorder
  • Medications that affect weight (determined by study staff)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Physical Activity Enhanced Weight Loss Intervention

    Standard Weight Loss Intervention

    Arm Description

    Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. This arm, uniquely, will receive a culturally based physical activity component.

    Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.

    Outcomes

    Primary Outcome Measures

    Change in Weight

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2015
    Last Updated
    April 17, 2017
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Academy of Nutrition and Dietetics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02631018
    Brief Title
    Sisters in Health: A Weight Loss Study for African American Women
    Official Title
    Sisters in Health: A Weight Loss Study for African American Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Academy of Nutrition and Dietetics

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effect of a physical activity-enhanced behavioral weight loss intervention, compared to a standard behavioral weight loss intervention in African American women.
    Detailed Description
    A disparity exists in the prevalence of overweight and obesity between non-Hispanic white (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA women, there is a higher prevalence, and almost double the risk, of developing T2DM compared to NHW. African Americans also have higher rates of complications and mortality from T2DM, and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic. Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and related diseases. Interventions to reduce overweight and obesity through lifestyle change have been less effective for AA women compared to NHW women. African American women tend to lose less weight in standard behavioral weight loss interventions. A potential reason for smaller weight loss is that compared to NHW women, AA women have been shown to engage in less physical activity (PA) during these interventions. The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial in overweight and obese African American women. Women will be recruited to participate in this study comparing a standard behavioral weight loss intervention (BWI) to a physical activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to determine if AA women randomized to the BWI-PA will experience greater weight loss and PA compared to women receiving the BWI. Women in both groups will receive 18 face-to-face sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women with the knowledge, behavioral skills and strategies for weight loss.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Activity Enhanced Weight Loss Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. This arm, uniquely, will receive a culturally based physical activity component.
    Arm Title
    Standard Weight Loss Intervention
    Arm Type
    Active Comparator
    Arm Description
    Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Weight Loss Intervention
    Intervention Description
    18 session, group-based, 6-month, standard behavioral weight loss intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical Activity Enhanced Weight Loss Intervention
    Intervention Description
    18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
    Primary Outcome Measure Information:
    Title
    Change in Weight
    Time Frame
    Baseline to 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 21-65 years old Ability to read, write, and speak English Female gender African American/Black/African/Afro-Caribbean race (self-identified) BMI 25-45 (> 45 may have greater risks while participating) Meets criteria for low active (defined as <3 days/week of at most 20 min. of PA/day) assessed by X Willingness to be randomized Willingness to participate for 6 months, including attending face-to-face sessions & outside of session tasks Access to a computer reliable internet access Willingness to use an app for diet and physical activity monitoring Regularly used email address Not planning to relocate Able to attend group sessions on scheduled day Exclusion Criteria: Recently lost weight, 5-10% in last 6 months Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities Pregnant or planning to become pregnant Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure) Type 2 diabetes being treated with insulin Major psychological disorder History of diagnosed eating disorder Medications that affect weight (determined by study staff)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah F. Tate, PhD
    Organizational Affiliation
    University of North Carolina, Chapel Hill
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Loneke T. Blackman Carr, MA, RD
    Organizational Affiliation
    University of North Carolina, Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Sisters in Health: A Weight Loss Study for African American Women

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