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

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ClinicalTrials.gov Identifier: NCT02198196
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Alere Wellbeing

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Weight Talk-Mindfulness Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs
Study Start Date : August 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Eating Inventory - Internal Disinhibition subscale [ Time Frame: Screening and 6-month follow-up ]
    8 items, screens for emotion and stress-related eating habits


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Screening and 6-month follow-up ]
    Weight in pounds


Other Outcome Measures:
  1. Mindful Eating Questionnaire [ Time Frame: Screening, 6-month follow-up ]
    28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating.

  2. Rapid Fruit and Vegetable Screener [ Time Frame: Screening, 6-month follow-up ]
    10-item scale that assesses fruit and vegetable intake.

  3. Fat Screener [ Time Frame: Screening, 6-month follow-up ]
    17-item scale that assesses fat intake

  4. Sweets Eating [ Time Frame: Screening, 6-month follow-up ]
    2-item scale that assesses high sugar food and drink intake

  5. Perceived Stress Scale - 4 item [ Time Frame: Screening, 6-month follow-up ]
    a 4-item scale that evaluates the appraisal of stress in one's life

  6. Binge Eating Scale [ Time Frame: Screening, 6-month follow-up ]
    16-item scale that assesses the presence of binge eating behaviors.

  7. Behavioral Obesity Phenotype Scale [ Time Frame: Screening, 6-month follow-up ]
    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.

  8. Acceptance and Action Questionnaire for Weight Related Difficulties [ Time Frame: Screening, 6-month follow-up ]
    22-item scale that measures acceptance and flexibility in relation to problematic thoughts and feelings regarding weight.

  9. Generalized Anxiety Disorder scale [ Time Frame: Screening, 6-month follow-up ]
    7-item diagnostic scale that assesses an individual's severity of anxiety and is used as a clinical screening tool for generalized anxiety disorder.

  10. Personal Health Questionnaire [ Time Frame: Screening, 6-month follow-up ]
    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.

  11. Adapted Physical Activity Measure [ Time Frame: Screening, 6-month follow-up ]
    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)

  12. Five Facet Mindfulness Questionnaire: Short Form [ Time Frame: Screening, 6-month follow-up ]
    24-item scale that measures non-judgmental awareness of thoughts, feelings, and physical sensations.

  13. Satisfaction and Adherence [ Time Frame: 6-month follow-up ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198196


Locations
United States, Washington
Alere Wellbeing, Inc
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Alere Wellbeing
Investigators
Study Chair: Lee Alekel, PhD National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Kelly Carpenter, PhD Alere Wellbeing
Principal Investigator: Jennifer Lovejoy, PhD

Responsible Party: Alere Wellbeing
ClinicalTrials.gov Identifier: NCT02198196     History of Changes
Other Study ID Numbers: 1R21AT007845-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms