Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.

Official Title
-----------------
Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
* Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of at least 30 kg/m^2 elevated stress levels based on perceived stress scale score self-identified as black race Exclusion Criteria: pregnant or are planning to become pregnant in the next year known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose > 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder) history of psychiatric hospitalization in past 2 years history of substance abuse or eating disorder any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated. currently taking medications for weight loss

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss Plus Stress Management<br>Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training | Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training<br>* 12-month evidence based weight loss intervention with additional training on stress management strategies<br>|
| Active Comparator: Weight Loss Only<br>Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics | Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics<br>* 12-month evidence based weight loss intervention with an attention control of general women's health topics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-month mean weight change of participants using SECA scale | weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged | Baseline to Month 4 | 
| 12-month mean weight change of participants using SECA scale | weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged | Baseline to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change in perceived stress using Perceived Stress Scale-10 score | Perceived stress as measured with a validated survey will be assessed at baseline and month to assess changes in participant's stress | Baseline to Month 4 | 
| mean change in perceived stress using Perceived Stress Scale-10 score | Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress | Baseline to Month 12 |