LIVE SMART: Smartphone Intervention for Weight Control

May 26, 2017 updated by: John Graham Thomas, The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control and Diabetes Resarch Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 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 will be weighed individually at the start of each group meeting.
Behavioral: Lifestyle Counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Active Comparator: Individual Treatment
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
Participants receive instructions for making healthy changes to their diet and physical activity habits.
Experimental: Smartphone Treatment
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
Participants receive instructions for making healthy changes to their diet and physical activity habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: Change from baseline to 18-months.
Change from baseline to 18-months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-related Behaviors
Time Frame: Change from baseline to 18-months.
Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.
Change from baseline to 18-months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement with Smartphone Treatment system
Time Frame: Mueasured continuously for the 18-month treatment.
Frequency and duration of use of intervention resources made available to the smartphone treatment arm.
Mueasured continuously for the 18-month treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK095779 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Lifestyle Counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe