LIVE SMART: Smartphone Intervention for Weight Control

NCT ID: NCT01724632

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle Counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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John Graham Thomas

Assistant Professor (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Weight Control and Diabetes Resarch Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38375882 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31556659 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30779333 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25475207 (View on PubMed)

Other Identifiers

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1R01DK095779

Identifier Type: NIH

Identifier Source: org_study_id

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