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

NCT ID: NCT02198196

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-01-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Weight Talk-Mindfulness

Intervention Type: BEHAVIORAL

Weight Talk-Standard

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Weight Talk-Mindfulness

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consumer Wellness Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Alekel, PhD

Role: STUDY_CHAIR

National Center for Complementary and Integrative Health (NCCIH)

Kelly Carpenter, PhD

Role: PRINCIPAL_INVESTIGATOR

Consumer Wellness Solutions

Jennifer Lovejoy, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

Alere Wellbeing, Inc

Seattle, Washington, United States

Countries

United States

Other Identifiers

1R21AT007845-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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