NCT01999244

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.5 years

First QC Date

November 25, 2013

Last Update Submit

September 21, 2015

Conditions

Keywords

OverweightObesityWeight LossSelf-monitoringFood RecordsSelf-weighingTechnology

Outcome Measures

Primary Outcomes (1)

  • Weight

    6 months post randomization

Study Arms (3)

SC

EXPERIMENTAL

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

Behavioral: Self-monitoring skills

TECH

EXPERIMENTAL

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

Behavioral: Self-monitoring skillsBehavioral: Technology

TECH+INT

EXPERIMENTAL

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

Behavioral: Self-monitoring skillsBehavioral: TechnologyBehavioral: Interventionist Contact

Interventions

SCTECHTECH+INT
TechnologyBEHAVIORAL
TECHTECH+INT
TECH+INT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

Technology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

  • Kathryn M Ross, PhD MPH

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR
  • Rena R Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 3, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations