NCT02198196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

July 21, 2014

Last Update Submit

February 3, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Eating Inventory - Internal Disinhibition subscale

    8 items, screens for emotion and stress-related eating habits

    Screening and 6-month follow-up

Secondary Outcomes (1)

  • Body weight

    Screening and 6-month follow-up

Other Outcomes (13)

  • Mindful Eating Questionnaire

    Screening, 6-month follow-up

  • Rapid Fruit and Vegetable Screener

    Screening, 6-month follow-up

  • Fat Screener

    Screening, 6-month follow-up

  • +10 more other outcomes

Study Arms (2)

Weight Talk-Mindfulness

EXPERIMENTAL

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

Weight Talk-Standard

NO INTERVENTION

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.

Interventions

Weight Talk-MindfulnessBEHAVIORAL
Weight Talk-Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Past diagnosis of anorexia nervosa or bulimia nervosa.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alere Wellbeing, Inc

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lee Alekel, PhD

    National Center for Complementary and Integrative Health (NCCIH)

    STUDY CHAIR

  • Kelly Carpenter, PhD

    Consumer Wellness Solutions

    PRINCIPAL INVESTIGATOR

  • Jennifer Lovejoy, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 23, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(1)