NCT00575731

Brief Summary

Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

December 16, 2007

Last Update Submit

May 18, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Weighing attitudes and behavior

    6 months

  • Weight fluctuations

    6 months

Secondary Outcomes (1)

  • Psychological outcomes

    6 months

Study Arms (2)

Fine-Tuning

EXPERIMENTAL

2-month intervention (8 lifestyle counseling classes)

Behavioral: Weight management strategies

Record-Keeping

ACTIVE COMPARATOR

2-month intervention (8 lifestyle counseling classes)

Behavioral: Weight management strategies

Interventions

Fine-TuningRecord-Keeping

Eligibility Criteria

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

You may not qualify if:

  • (b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michaela Kiernan

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

December 16, 2007

First Posted

December 18, 2007

Study Start

July 1, 2006

Primary Completion

April 1, 2008

Study Completion

May 1, 2009

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations