The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Standard Weight Loss Intervention; Behavioral: Stress-Focused Weight Loss Intervention

• Registration Number: NCT02253641
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This study evaluates the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI \> 40.0) African American women.

Detailed Description

Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors (e.g. diet and exercise) among African American women. African American women consistently lose less weight than their Caucasian counterparts in weight loss interventions. One reason for this disparity may be due to the failure of most weight loss interventions to address stress management adequately or in a culturally competent way.

The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI \> 40.0) African American women. The stress-focused weight loss intervention will incorporate stress management content throughout the entire intervention and will include content that is culturally tailored. The standard weight loss intervention will cover stress management techniques during one of the 14 sessions and the material will be more generic in nature (e.g. not culturally tailored).

Study Timeline

• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-10-01
• Study Start: 2015-04
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-20
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• African American (self-identified)
• Female
• BMI > 40 kg/m2
• Access to internet connection and phone for personal use

Exclusion Criteria

• Unable to walk without the use of an assistance device
• Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q) or unable to attain medical clearance from their doctor
• Substance abuse within past two years
• Schizophrenia
• Currently pregnant, pregnant within the past 6 months or plans to become pregnant in the next 6 months
• History of malignancy other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years
• Participation in a weight loss program in the past 12 months
• > 5% loss of body weight within the past 6 months
• Bariatric surgery recipient
• Heart attack in the past 6 months
• Stroke within the past 6 months

NOTE: Participants who "fail" the PAR-Q will be required to obtain medical clearance from their medical provider

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Weight Loss Intervention	Standard Weight Loss Intervention	Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al. (Samuel-Hodge, Carmen D., et al. "Randomized Trial of a Behavioral Weight Loss Intervention for Low?income Women: The Weight Wise Program." Obesity 17.10 (2009): 1891-1899). The only modifications to the content (other than some general formatting) will be the combining of sessions 3 and 4 and sessions 6 and 7. These changes will allow us to fit the original 16-session curriculum into the 14-session format of our intervention.
Stress-Focused Weight Loss Intervention	Stress-Focused Weight Loss Intervention	Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al.. The participants in this arm will receive all of the content that the comparison group receives (just moderately condensed to allow time for additional components) plus a stress-reduction intervention woven into each of the sessions. The stress-reduction content aims to reduce stress by helping participants: (1) identifying and reducing exposure (to the degree possible) of current stressors, (2) change their perceptions of current stressors and (3) use healthier stress-coping techniques (e.g. yoga, meditation, etc.)

Primary Outcome Measures

Name	Time	Method
Weight	Change from Baseline to 6 Months	collect weight in pounds

Secondary Outcome Measures

Name	Time	Method
Physical Activity	Change from Baseline to 6 Months	participants will wear accelerometer for 1 week at each time point
Psychosocial & Behavioral Measures	Change from Baseline to 6 Months	Participants will complete a survey that will assess varying psychosocial and behavioral measures including: (1) diet and exercise habits, (2) stress levels, (3) moods and (4) attitudes and beliefs regarding female stereotypes.
Walkability	Change from Baseline to 6 Months	Stand Up and Go Test
Aerobic Fitness	Change from Baseline to 6 Months	6 Minute Walk Test

Trial Locations

Locations (1)

UNC Center for Health Promotion and Disease Prevention; 🇺🇸 Chapel-Hill, North Carolina, United States