NCT02671110

Brief Summary

This study compared the recently developed Transforming Your Life (TYL) weight loss program to the Diabetes Prevention Program (DPP), considered the "Gold Standard" in behavioral weight loss treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

November 2, 2015

Last Update Submit

January 29, 2016

Conditions

Keywords

weight loss treatmentObesity

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    lbs

    10 months

Secondary Outcomes (2)

  • Caloric Intake

    4 months

  • Energy expenditure

    4 months

Study Arms (2)

Transforming Your Life

EXPERIMENTAL

The TYL program emphasized: 1) helping participants develop and maintain healthy habits and disrupt unhealthy habits, 2) enabling participants to create a personal food and exercise environment that increases exposure to healthy eating and physical activity and encourages automatic responding to goal-related cues, and 3) facilitating participants' weight loss motivation.

Behavioral: Transforming Your Life

Diabetes Prevention program

ACTIVE COMPARATOR

The DPP recommends that participants set a weight loss reduction goal of 7% or more of their baseline body weight, reduce consumption of high fat foods as a means to reduce caloric intake, and engage in brisk walking or other moderate intensity physical activity for 150 minutes per week. Sessions include information on changing energy intake and energy output through diet and exercise, and addressing psychological, social, environmental, and motivational challenges to health behavior change.

Behavioral: Diabetes Prevention Program

Interventions

See Transforming Your Life Arm

Transforming Your Life

See Diabetes Prevention Program Arm

Diabetes Prevention program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • overweight/obese (body mass index\>27 kg/m2)
  • free from serious medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
  • had not undergone bariatric surgery
  • able to provide medical clearance from their physician.

You may not qualify if:

  • evidence of medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
  • had undergone bariatric surgery,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bowling Green State University

Bowling Green, Ohio, 43403, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2015

First Posted

February 2, 2016

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 2, 2016

Record last verified: 2016-01

Locations