Clinical trial NCT02198196: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Consumer Wellness Solutions
Sponsor class: INDUSTRY
First posted: 2014-07-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Eating Inventory - Internal Disinhibition subscale
timeFrame: Screening and 6-month follow-up
Secondary outcomes:
measure: Body weight
timeFrame: Screening and 6-month follow-up
Other outcomes:
measure: Mindful Eating Questionnaire
timeFrame: Screening, 6-month follow-up
measure: Rapid Fruit and Vegetable Screener
timeFrame: Screening, 6-month follow-up
measure: Fat Screener
timeFrame: Screening, 6-month follow-up
measure: Sweets Eating
timeFrame: Screening, 6-month follow-up
measure: Perceived Stress Scale - 4 item
timeFrame: Screening, 6-month follow-up
measure: Binge Eating Scale
timeFrame: Screening, 6-month follow-up
measure: Behavioral Obesity Phenotype Scale
timeFrame: Screening, 6-month follow-up
measure: Acceptance and Action Questionnaire for Weight Related Difficulties
timeFrame: Screening, 6-month follow-up
measure: Generalized Anxiety Disorder scale
timeFrame: Screening, 6-month follow-up
measure: Personal Health Questionnaire
timeFrame: Screening, 6-month follow-up
measure: Adapted Physical Activity Measure
timeFrame: Screening, 6-month follow-up
measure: Five Facet Mindfulness Questionnaire: Short Form
timeFrame: Screening, 6-month follow-up
measure: Satisfaction and Adherence
timeFrame: 6-month follow-up
Locations:
city: Seattle
country: United States
facility: Alere Wellbeing, Inc
state: Washington
Study officials:
affiliation: National Center for Complementary and Integrative Health (NCCIH)
name: Lee Alekel, PhD
role: STUDY_CHAIR
affiliation: Consumer Wellness Solutions
name: Kelly Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
name: Jennifer Lovejoy, PhD
role: PRINCIPAL_INVESTIGATOR
References: