Is Monitoring Activity Important for Short- and Long-term Weight Loss?

Overweight and Obesity Clinical Trial

— UHPAWS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544245
• Other study ID #: 437846
• Status: Completed
• Phase: N/A
• First received: October 12, 2007
• Last updated: August 14, 2011
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2011
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The major objective of this study is to determine if two techniques for monitoring physical activity and energy balance promote the maintenance of weight loss in healthy overweight and obese individuals. The study compares two approaches designed to help individuals monitor physical activity and to adjust their calorie intake to maintain a reasonable energy balance (bodybugg® & Step Diet Book systems). Full subject participation in the study spans two years. Participants periodically report to a pre-arranged location to be measured by a qualified fitness professional for height, weight, circumferences, and estimated body fat using a bioelectric impedance scale (body fat scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Desire to lose weight

• Height: 60-76 inches

• BMI 27-40

• Healthy

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Self monitoring of estimated energy balance
Participant estimation of energy intake and energy expenditure

Locations

Country	Name	City	State
United States	Univ of Hawaii Dept of Human Nutrition, Food & Animal Sci	Honolulu	Hawaii

Sponsors (3)

Lead Sponsor	Collaborator
University of Hawaii	Bookman Publishing Company, The Apex Fitness Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measures of body weight, body circumferences, and estimated body composition		2 years	No