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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Weight Talk-Mindfulness

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Alere Wellbeing, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Weight Talk-Mindfulness
No Intervention: 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindful Eating Questionnaire	28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating.	Screening, 6-month follow-up
Rapid Fruit and Vegetable Screener	10-item scale that assesses fruit and vegetable intake.	Screening, 6-month follow-up
Fat Screener	17-item scale that assesses fat intake	Screening, 6-month follow-up
Sweets Eating	2-item scale that assesses high sugar food and drink intake	Screening, 6-month follow-up
Perceived Stress Scale - 4 item	a 4-item scale that evaluates the appraisal of stress in one's life	Screening, 6-month follow-up
Binge Eating Scale	16-item scale that assesses the presence of binge eating behaviors.	Screening, 6-month follow-up
Behavioral Obesity Phenotype Scale	8-item scale that assesses lack of control, lack of satiation, and preoccupation with food. We include 6 out of the 8 original items; 2 of the items already exist in the Binge Eating Scale (BES). One additional Preoccupation with Food item was added.	Screening, 6-month follow-up
Acceptance and Action Questionnaire for Weight Related Difficulties	22-item scale that measures acceptance and flexibility in relation to problematic thoughts and feelings regarding weight.	Screening, 6-month follow-up
Generalized Anxiety Disorder scale	7-item diagnostic scale that assesses an individual's severity of anxiety and is used as a clinical screening tool for generalized anxiety disorder.	Screening, 6-month follow-up
Personal Health Questionnaire	2-item scale that assesses the frequency of depressed mood over the past 2 weeks and is used as a preliminary screening tool for depression.	Screening, 6-month follow-up
Adapted Physical Activity Measure	11-item scale that assesses overall activity level over the past week, adapted from measure used in the National Health and Nutrition Examination Survey (NHANES)	Screening, 6-month follow-up
Five Facet Mindfulness Questionnaire: Short Form	24-item scale that measures non-judgmental awareness of thoughts, feelings, and physical sensations.	Screening, 6-month follow-up
Satisfaction and Adherence	11-item measure consisting of Likert scale and open-ended questions about the participants' experience with the intervention and their adherence to mindfulness practice assignments.	6-month follow-up

Collaborators and Investigators

• Sponsor: Consumer Wellness Solutions
• Investigators: Study Chair: Lee Alekel, PhD, National Center for Complementary and Integrative Health (NCCIH); Principal Investigator: Kelly Carpenter, PhD, Consumer Wellness Solutions; Principal Investigator: Jennifer Lovejoy, PhD

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 1R21AT007845-01A1 (U.S. NIH Grant/Contract)