NCT00702455

Brief Summary

The goal of this project is to test whether a phone and mail-based program designed to help people who have recently lost weight helps them keep the weight off over a 2 year period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
419

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

3.4 years

First QC Date

June 18, 2008

Last Update Submit

November 19, 2012

Conditions

Weight Loss Maintenance

Keywords

Weight loss maintenance.Interactive phone and mail-based intervention.

Outcome Measures

Primary Outcomes (1)

  • Weight: Weight change in kilograms at 24 month follow-up. We hypothesize that Guided participants will regain less weight than the Self-Directed participants.

    24 months

Secondary Outcomes (1)

  • assessments of subgroup analysis of intervention effectiveness (e.g., BMI status, weight loss method, gender.

    24 months

Study Arms (2)

Self-Directed

ACTIVE COMPARATOR
Behavioral: Self-Directed (weight loss maintenance)

Guided

ACTIVE COMPARATOR
Behavioral: Guided (weight loss maintenance)

Interventions

Self-Directed (weight loss maintenance)BEHAVIORAL

Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach in two sessions.

Self-Directed
Guided (weight loss maintenance)BEHAVIORAL

Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their weight gain.

Guided

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 19 and 70
  • HealthPartners members for 11 out of the past 12 months
  • Have lost at least 10% of body weight in the last 12 months

You may not qualify if:

  • Lost weight via gastric by-pass surgery
  • Modified Charlson scores \>=3
  • Nonskin cancer
  • Congestive heart failure
  • Coronary heart disease
  • Psychotic illness
  • Substance abuse
  • Terminal illness
  • Diagnosed eating disorder
  • BMI\<20.5 or \>45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Research Foundation

Bloomington, Minnesota, 55425, United States

Location

Related Publications (3)

  • Crain AL, Sherwood NE, Martinson BC, Jeffery RW. Mediators of Weight Loss Maintenance in the Keep It Off Trial. Ann Behav Med. 2018 Jan 5;52(1):9-18. doi: 10.1007/s12160-017-9917-x.

    PMID: 28508330DERIVED

  • Crane MM, Jeffery RW, Sherwood NE. Exploring Gender Differences in a Randomized Trial of Weight Loss Maintenance. Am J Mens Health. 2017 Mar;11(2):369-375. doi: 10.1177/1557988316681221. Epub 2016 Dec 5.

    PMID: 27923968DERIVED

  • Senso MM, Anderson CP, Crain AL, Sherwood NE, Martinson BC. Self-reported activity and accelerometry in 2 behavior-maintenance trials. Am J Health Behav. 2014 Mar;38(2):254-64. doi: 10.5993/AJHB.38.2.11.

    PMID: 24629554DERIVED

Study Officials

  • Nancy E. Sherwood, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 20, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2010

Study Completion

July 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

US(1)