The Short-Term Effect of a Technology Driven Weight Control (SMART) Program for Obese Adults

NCT ID: NCT00624598

Last Updated: 2008-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to evaluate the short-term effect of a technology based weight reduction program for obese (BMI \> 30 kg/m2) adults in a primary care office.

Detailed Description

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Conditions

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Obesity Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SMART Group

The experimental group will have a nutrition program based solely on measured resting metabolic rate. The nutrition plan will be a specific calorie level that will promote a 1-2.5 lb per week weight reduction. No experimental participants' nutrition plan will be below 1200 Kcal/day for women or 1600 Kcal/day for men. Second, the experimental group will receive a downloadable copy of a computerized nutrition software program (BalanceLog: Microlife USA, Inc. Golden, CO) that functions s on a Windows 2000-XP or Palm operating system.

Group Type EXPERIMENTAL

SMART

Intervention Type BEHAVIORAL

Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.

Usual Care

Standard 1200 kcal/day diet (women) 1600 kcal/day diet (men) using a sample 3-day menu program. The diet will be follow current government based recommendations for carbohydrates (i.e. 55%), fat (30%), and protein (15%). Study participants will receive a standard paper-based food and exercise journal

Group Type ACTIVE_COMPARATOR

SMART

Intervention Type BEHAVIORAL

Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.

Interventions

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SMART

Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Participant between the ages of 18-65 years.
2. Participant with a BMI (Body Mass Index \> 30.0 kg/m2)
3. Have access and use email a minimum of 2-days per week.

Exclusion Criteria

1. Participant is not pregnant or lactating: Weight loss is not recommended for pregnant women and extra energy requirements are essential for fetal development (Butte, Wong, Treuth, Ellis, \& O'Brian Smith, 2004; Durnin, 1991).
2. Participant is not currently participating in any structured/self-help weight loss program. The elimination of individuals actively participating in a current weight loss program will reduce the potential of a carry-over effect from these weight loss modalities (Fife-Shaw, 2006).
3. Participant has not attempted weight loss in the past 3 months. Same as number two.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Microlife

INDUSTRY

Sponsor Role collaborator

Colorado Center for Chronic Care Innovations, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Capella University

Locations

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Westmed Family Healthcare

Westminster, Colorado, United States

Site Status

Westminster Medical Center

Westminster, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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C41 # 001

Identifier Type: -

Identifier Source: org_study_id