NCT01760486

Brief Summary

The investigators have shown that adding an internet behavioral weight loss program to a statewide campaign improves weight loss outcomes. However, our follow-up data suggest that once the intervention is stopped, participants begin to experience weight regain. Thus, the purpose of this project is extend this line of work and pilot test health coaches and monetary incentives for weight loss maintenance. The investigators hypothesize that coaching and incentives will improve longer-term weight outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

January 2, 2013

Last Update Submit

January 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight change from month 2 (i.e. immediately following the weight loss phase) to the 12 month follow-up assessment measured on a digital scale to the nearest 0.1 kilogram

    2 to 12 months

Study Arms (3)

Shape Up Rhode Island

ACTIVE COMPARATOR

Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive periodic newsletters throughout the 12 month trial.

Behavioral: Shape Up Rhode Island

Shape Up Rhode Island + Professional Coach + Incentives

EXPERIMENTAL

Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive a professional weight loss coach and will be incentivized for submitting information to their coach and meeting weight goals.

Behavioral: Shape Up Rhode Island + Professional Coach + Incentives

Shape Up Rhode Island + Peer Coach + Incentives

EXPERIMENTAL

Individuals who join Shape Up Rhode Island 2013, enter our research study, and lose 5% of their initial body weight during the first two months of Shape Up will be randomized to one of the three maintenance interventions. If randomized to this treatment arm, participants will receive a peer coach and will be incentivized for reporting to their coach and meeting weight goals.

Behavioral: Shape Up Rhode Island + Peer Coach + Incentives

Interventions

Shape Up Rhode Island
Shape Up Rhode Island + Professional Coach + Incentives
Shape Up Rhode Island + Peer Coach + Incentives

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index \>=25kg/m2
  • English speaking

You may not qualify if:

  • Health problems that make weight loss or unsupervised exercise unsafe
  • Current pregnancy or plan to become pregnant in the next 12 months
  • Planned relocation
  • Previous participation in Shape Up Rhode Island research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

January 2, 2013

First Posted

January 4, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 12, 2016

Record last verified: 2013-12

Locations