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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198196
• Other study ID #: 1R21AT007845-01A1
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: February 3, 2016
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Alere Wellbeing
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Weight Talk-Mindfulness

Locations

Country	Name	City	State
United States	Alere Wellbeing, Inc	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Alere Wellbeing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mindful Eating Questionnaire	28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating.	Screening, 6-month follow-up	No
Other	Rapid Fruit and Vegetable Screener	10-item scale that assesses fruit and vegetable intake.	Screening, 6-month follow-up	No
Other	Fat Screener	17-item scale that assesses fat intake	Screening, 6-month follow-up	No
Other	Sweets Eating	2-item scale that assesses high sugar food and drink intake	Screening, 6-month follow-up	No
Other	Perceived Stress Scale - 4 item	a 4-item scale that evaluates the appraisal of stress in one's life	Screening, 6-month follow-up	No
Other	Binge Eating Scale	16-item scale that assesses the presence of binge eating behaviors.	Screening, 6-month follow-up	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	Eating Inventory - Internal Disinhibition subscale	8 items, screens for emotion and stress-related eating habits	Screening and 6-month follow-up	No
Secondary	Body weight	Weight in pounds	Screening and 6-month follow-up	No