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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Talk-Mindfulness
Sponsored by
Consumer Wellness Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alere Wellbeing, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Weight Talk-Mindfulness

Weight Talk-Standard

Arm 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.

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.

Outcomes

Primary Outcome Measures

Eating Inventory - Internal Disinhibition subscale
8 items, screens for emotion and stress-related eating habits

Secondary Outcome Measures

Body weight
Weight in pounds

Full Information

First Posted
July 21, 2014
Last Updated
February 3, 2016
Sponsor
Consumer Wellness Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT02198196
Brief Title
Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs
Official Title
Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consumer Wellness Solutions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Talk-Mindfulness
Arm Type
Experimental
Arm 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.
Arm Title
Weight Talk-Standard
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Talk-Mindfulness
Primary Outcome Measure Information:
Title
Eating Inventory - Internal Disinhibition subscale
Description
8 items, screens for emotion and stress-related eating habits
Time Frame
Screening and 6-month follow-up
Secondary Outcome Measure Information:
Title
Body weight
Description
Weight in pounds
Time Frame
Screening and 6-month follow-up
Other Pre-specified Outcome Measures:
Title
Mindful Eating Questionnaire
Description
28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating.
Time Frame
Screening, 6-month follow-up
Title
Rapid Fruit and Vegetable Screener
Description
10-item scale that assesses fruit and vegetable intake.
Time Frame
Screening, 6-month follow-up
Title
Fat Screener
Description
17-item scale that assesses fat intake
Time Frame
Screening, 6-month follow-up
Title
Sweets Eating
Description
2-item scale that assesses high sugar food and drink intake
Time Frame
Screening, 6-month follow-up
Title
Perceived Stress Scale - 4 item
Description
a 4-item scale that evaluates the appraisal of stress in one's life
Time Frame
Screening, 6-month follow-up
Title
Binge Eating Scale
Description
16-item scale that assesses the presence of binge eating behaviors.
Time Frame
Screening, 6-month follow-up
Title
Behavioral Obesity Phenotype Scale
Description
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.
Time Frame
Screening, 6-month follow-up
Title
Acceptance and Action Questionnaire for Weight Related Difficulties
Description
22-item scale that measures acceptance and flexibility in relation to problematic thoughts and feelings regarding weight.
Time Frame
Screening, 6-month follow-up
Title
Generalized Anxiety Disorder scale
Description
7-item diagnostic scale that assesses an individual's severity of anxiety and is used as a clinical screening tool for generalized anxiety disorder.
Time Frame
Screening, 6-month follow-up
Title
Personal Health Questionnaire
Description
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.
Time Frame
Screening, 6-month follow-up
Title
Adapted Physical Activity Measure
Description
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)
Time Frame
Screening, 6-month follow-up
Title
Five Facet Mindfulness Questionnaire: Short Form
Description
24-item scale that measures non-judgmental awareness of thoughts, feelings, and physical sensations.
Time Frame
Screening, 6-month follow-up
Title
Satisfaction and Adherence
Description
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.
Time Frame
6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Alekel, PhD
Organizational Affiliation
National Center for Complementary and Integrative Health (NCCIH)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kelly Carpenter, PhD
Organizational Affiliation
Consumer Wellness Solutions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Lovejoy, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alere Wellbeing, Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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