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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Weight Talk-Mindfulness

• Registration Number: NCT02198196
• Lead Sponsor: Consumer Wellness Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Study Start: 2014-08
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Weight Talk-Mindfulness	Weight Talk-Mindfulness	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.

Primary Outcome Measures

Name	Time	Method
Eating Inventory - Internal Disinhibition subscale	Screening and 6-month follow-up	8 items, screens for emotion and stress-related eating habits

Secondary Outcome Measures

Name	Time	Method
Body weight	Screening and 6-month follow-up	Weight in pounds

Trial Locations

Locations (1)

Alere Wellbeing, Inc; 🇺🇸 Seattle, Washington, United States