NCT00544245

Brief Summary

This study is comparing the effectiveness of two techniques for monitoring physical activity and energy balance on long-term weight management (two years). The focus is on weight loss, prevention of weight gain, and the maintenance of a healthy weight over time. It is expected that both techniques will benefit long-term weight management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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

October 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

2.9 years

First QC Date

October 12, 2007

Last Update Submit

August 14, 2011

Conditions

Keywords

overweightobesityaccelerometerpedometerenergy balanceweight lossweight maintenance

Outcome Measures

Primary Outcomes (1)

  • Change in measures of body weight, body circumferences, and estimated body composition

    2 years

Interventions

Participant estimation of energy intake and energy expenditure

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Desire to lose weight
  • Height: 60-76 inches
  • BMI 27-40
  • Healthy

You may not qualify if:

  • Currently enrolled in a weight loss program
  • Currently under medical care for obesity treatment
  • Using drug, supplement, or similar treatment to promote weight loss
  • Have undergone bariatric surgery or have breast implants
  • Intend to have surgery within the next 24 months
  • Have had an eating disorder
  • Are pregnant, breast-feeding, or plan to become pregnant within 24 months
  • Are planning an extended vacation, absence, or relocation within 24 months
  • Use tobacco products
  • Frequently consume 2 or more alcoholic drinks per day
  • Use illegal drugs, steroids, or growth hormone
  • Use any appetite-affecting medications
  • Are eating a physician-supervised diet
  • Have other problems that might interfere with ability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Hawaii Dept of Human Nutrition, Food & Animal Sci

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Charles A Titchenal, PhD

    Human Nutrition, Food & Animal Sci / Univ of Hawaii

    PRINCIPAL INVESTIGATOR
  • Joannie C Dobbs, PhD

    Human Nutrition, Food & Animal Sci / Univ of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations