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Completed

NCT Number: NCT02198196

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alere Wellbeing, Inc

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Talk-Mindfulness

Behavioral

Primary outcomes

  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 outcomes

  1. Body weight

    Time frame: Screening and 6-month follow-up

    Weight in pounds

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Consumer Wellness Solutions

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2014
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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