Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. The control group will receive a standard phone-based program with no additional stress management information (Weight Talk-Standard). Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience decreases in their stress-related & emotion-related eating compared to the Weight Talk-Standard (WT-S; n=25) group. Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group. Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased eating self-efficacy, increased acceptance of weight-related thoughts & feelings and increased mindfulness compared to those in the WT-S control arm. Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss program as those in WT-S.

Official Title
-----------------
Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs

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

Intervention / Treatment
-----------------
* Behavioral: Weight Talk-Mindfulness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be enrolled in the Weight Talk program, inclusion criteria: Employment by one of the employers who contract for Weight Talk services Being over 18 years of age Speak and read English Have a starting BMI between 25 and 35. Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating Inventory. Have regular access to email and internet. Willingness and ability to complete study and intervention procedures, including completing assessments, engaging in moderate physical activity (e.g., walking, swimming) and using the electronic scale at least once per week. Exclusion Criteria: Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program). Past diagnosis of anorexia nervosa or bulimia nervosa. Weight Talk program exclusion criteria include: Pregnancy Bariatric surgery within past 12 months or planned in the next 6 months Undergoing dialysis Have Type 1 Diabetes diagnosis Women who are pregnant are not eligible for the program, but contraception is not required as this is a low risk study Currently using or planning to start using a pharmaceutical weight loss drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Talk-Mindfulness<br>WT-M retain the evidence-based elements of WT-S (control condition), including the DASH diet, physical activity components, and an emphasis on self-monitoring. However, each call in WT-M will include an emphasis on mindfulness and stress management that will not be included in the control condition. | Behavioral: Weight Talk-Mindfulness<br> <br> |
| No Intervention: Weight Talk-Standard<br>Weight Talk-Standard is a phone and web-based weight loss intervention offered by employers as a benefit to their employees. Weight Talk is based on the NIH Clinical Guidelines on Identification, Evaluation and Treatment of Overweight and Obesity in Adults and utilizes the curriculum developed for the Diabetes Prevention Program. Weight Talk-S contains no additional stress management techniques. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Inventory - Internal Disinhibition subscale | 8 items, screens for emotion and stress-related eating habits | Screening and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Weight in pounds | Screening and 6-month follow-up |