Obesity
Conditions
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.
Interventions
BEHAVIORALDiabetes Prevention Program Intensive Lifestyle Intervention plus stress management training
12-month evidence based weight loss intervention with additional training on stress management strategies
BEHAVIORALDiabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
12-month evidence based weight loss intervention with an attention control of general women's health topics
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4-month mean weight change of participants using SECA scale | Baseline to Month 4 | weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged |
| 12-month mean weight change of participants using SECA scale | Baseline to Month 12 | weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean change in perceived stress using Perceived Stress Scale-10 score | Baseline to Month 4 | Perceived stress as measured with a validated survey will be assessed at baseline and month to assess changes in participant's stress |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTiffany L Carson, PhD
Moffitt Cancer Center
Outcome results
None listed