Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss

NCT ID: NCT01999244

Last Updated: 2015-09-23

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

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Despite continued research on effective interventions, obesity remains a major public health issue in the United States. Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight. Despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented. Two key questions need to be addressed. First, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact? Second, how cost-effective is a technology-based intervention, with and without interventionist contact? The current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to a technology only condition (TECH) and a technology plus interventionist support condition (TECH+INT). All participants will all be given basic weight management information knowledge and randomized to one of three conditions. Participants in the self-guided self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (TECH+INT) will receive the same technology as in the TECH condition, combined with weekly interventionist contact delivered via telephone. We will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness.

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

SINGLE

Outcome Assessors

Study Groups

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SC

Self-guided self-monitoring condition. Participants will receive standard self-monitoring tools and information on weight regulation.

Group Type EXPERIMENTAL

Self-monitoring skills

Intervention Type BEHAVIORAL

TECH

Technology condition. Participants will receive self-monitoring technology and information regarding weight regulation.

Group Type EXPERIMENTAL

Self-monitoring skills

Intervention Type BEHAVIORAL

Technology

Intervention Type BEHAVIORAL

TECH+INT

Technology plus interventionist contact arm. Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone.

Group Type EXPERIMENTAL

Self-monitoring skills

Intervention Type BEHAVIORAL

Technology

Intervention Type BEHAVIORAL

Interventionist Contact

Intervention Type BEHAVIORAL

Interventions

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Self-monitoring skills

Intervention Type BEHAVIORAL

Technology

Intervention Type BEHAVIORAL

Interventionist Contact

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 70
* BMI between 27 and 40 kg/m2
* Access to a computer and WIFI in the home

Exclusion Criteria

* Weight over 340 lbs
* Physical limitations that prevent walking 1/4 mile without stopping
* Currently participating in another weight loss program or taking weight loss medication
* Currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period
* Uncontrolled hypertension or diabetes
* History of coronary heart disease
* Terminal Illness
* Plans to relocate during the 6-month study period
* Substance Abuse
* Severe psychiatric disorders
* Dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn M Ross, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Rena R Wing, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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Weight Control & Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.

Reference Type DERIVED
PMID: 32720911 (View on PubMed)

Ross KM, Wing RR. Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study. Obesity (Silver Spring). 2016 Aug;24(8):1653-9. doi: 10.1002/oby.21536. Epub 2016 Jul 1.

Reference Type DERIVED
PMID: 27367614 (View on PubMed)

Other Identifiers

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F32DK100069-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

209313

Identifier Type: -

Identifier Source: org_study_id

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