NCT01724632

Brief Summary

The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

November 6, 2012

Last Update Submit

May 26, 2017

Conditions

Keywords

OverweightObesityWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Change from baseline to 18-months.

Secondary Outcomes (1)

  • Weight-related Behaviors

    Change from baseline to 18-months.

Other Outcomes (1)

  • Engagement with Smartphone Treatment system

    Mueasured continuously for the 18-month treatment.

Study Arms (3)

Group Treatment

ACTIVE COMPARATOR

Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.

Behavioral: Lifestyle Counseling

Individual Treatment

ACTIVE COMPARATOR

Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.

Behavioral: Lifestyle Counseling

Smartphone Treatment

EXPERIMENTAL

Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.

Behavioral: Lifestyle Counseling

Interventions

Participants receive instructions for making healthy changes to their diet and physical activity habits.

Group TreatmentIndividual TreatmentSmartphone Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (kg/m2) of 25-45.
  • English language fluency
  • Ability to read at a 6th grade level
  • Availability to attend weekly treatment sessions in Providence, RI

You may not qualify if:

  • Any heart condition that limits ability to participate in physical activity
  • Chest Pain
  • Any cognitive of physical limitation that would preclude use of a smartphone
  • Serious mental illness
  • Historical or current eating disorder
  • Previous or planned bariatric surgery
  • Use of weight loss medication
  • Recent pregnancy or a plan to become pregnant in the next 6 months
  • Participation in a study at the Weight Control and Diabetes Research Center within the last two years
  • A weight loss of greater than 5% body weight in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  • Goldstein SP, Goldstein CM, Bond DS, Raynor HA, Wing RR, Thomas JG. Associations between self-monitoring and weight change in behavioral weight loss interventions. Health Psychol. 2019 Dec;38(12):1128-1136. doi: 10.1037/hea0000800. Epub 2019 Sep 26.

  • Thomas JG, Bond DS, Raynor HA, Papandonatos GD, Wing RR. Comparison of Smartphone-Based Behavioral Obesity Treatment With Gold Standard Group Treatment and Control: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):572-580. doi: 10.1002/oby.22410. Epub 2019 Feb 19.

  • Bond DS, Thomas JG, O'Leary KC, Lipton RB, Peterlin BL, Roth J, Rathier L, Wing RR. Objectively measured physical activity in obese women with and without migraine. Cephalalgia. 2015 Sep;35(10):886-93. doi: 10.1177/0333102414562970. Epub 2014 Dec 4.

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 12, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations