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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631018
• Other study ID #: 15-0484
• Status: Completed
• Phase: N/A
• First received: December 11, 2015
• Last updated: April 17, 2017
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Standard Weight Loss Intervention
18 session, group-based, 6-month, standard behavioral weight loss intervention
• Physical Activity Enhanced Weight Loss Intervention
18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Academy of Nutrition and Dietetics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight		Baseline to 6 months

External Links

•   Study website