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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Standard Weight Loss Intervention
* Behavioral: Stress-Focused Weight Loss Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Weight Loss Intervention<br>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. | Behavioral: Standard Weight Loss Intervention<br>* 14-session/6-month standard behavioral weight loss intervention<br>|
| Experimental: Stress-Focused Weight Loss Intervention<br>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.) | Behavioral: Stress-Focused Weight Loss Intervention<br>* 14-session/6-month tailored behavioral weight loss intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | collect weight in pounds | Change from Baseline to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | participants will wear accelerometer for 1 week at each time point | Change from Baseline to 6 Months | 
| Psychosocial & Behavioral Measures | 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. | Change from Baseline to 6 Months | 
| Walkability | Stand Up and Go Test | Change from Baseline to 6 Months | 
| Aerobic Fitness | 6 Minute Walk Test | Change from Baseline to 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, Women, Weight Loss