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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Physical Activity Enhanced Weight Loss Intervention; Behavioral: Standard Weight Loss Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity Enhanced Weight Loss Intervention; 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.	Behavioral: Physical Activity Enhanced Weight Loss Intervention; 18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
Active Comparator: Standard Weight Loss Intervention; 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.	Behavioral: Standard Weight Loss Intervention; 18 session, group-based, 6-month, standard behavioral weight loss intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Weight	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Academy of Nutrition and Dietetics
• Investigators: Study Chair: Deborah F. Tate, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Loneke T. Blackman Carr, MA, RD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 15-0484