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

Consumer Wellness Solutions

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Weight Talk-Mindfulness

Study type: Interventional

Funder types: Industry

Identifiers

NCT02198196

1R21AT007845-01A1

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Weight Talk-Mindfulness

Experimental group

Description:

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.

Treatment:

Behavioral: Weight Talk-Mindfulness

Weight Talk-Standard

No Intervention group

Description:

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.