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

Sponsors and Collaborators:	Colorado Center for Chronic Care Innovations, Inc. Microlife
Information provided by:	Colorado Center for Chronic Care Innovations, Inc.
ClinicalTrials.gov Identifier:	NCT00624598

Purpose

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.

Condition	Intervention
Obesity Hypertension	Behavioral: SMART

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Phase I Study of Integrating RMR Technology and Email Counseling in a PCP Office.

Resource links provided by NLM:

MedlinePlus related topics: Diets High Blood Pressure Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Colorado Center for Chronic Care Innovations, Inc.:

Primary Outcome Measures:

Individuals receiving a technology-based weight reduction program will not have a significant increase in psychosocial constructs (i.e. weight self-efficacy, perceived behavioral control, attitude) compared to control group. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Individuals receiving a technology-based weight reduction program will not improve eating behaviors (i.e. dietary cognitive restraint, emotional eating, uncontrolled eating) compared to control group. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Individuals receiving a technology-based weight reduction program will not lose significantly more weight compared to control group. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Individuals receiving a technology-based weight reduction program will not significantly improve systolic and diastolic blood pressure compared to control group(controlled for Bp medications). [ Time Frame: 10 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Individuals receiving a technology-based weight reduction program will not significantly improve weight quality of life compared to control group. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
There is no relationship between psychosocial values (i.e. weight self-efficacy, weight perceived behavioral control, weight attitude) and eating behaviors (i.e. dietary cognitive restraint, uncontrolled eating, and emotional eating). [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	January 2008
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SMART Group: Experimental 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.	Behavioral: 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.
Usual Care: Active Comparator 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	Behavioral: 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.

Arms

Assigned Interventions

SMART Group: Experimental

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.

Behavioral: 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.

Usual Care: Active Comparator

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

Behavioral: 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).
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).
Participant has not attempted weight loss in the past 3 months. Same as number two.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624598

Locations

United States, Colorado
Westminster Medical Center
Westminster, Colorado, United States, 80031
Westmed Family Healthcare
Westminster, Colorado, United States, 80031

Sponsors and Collaborators

Colorado Center for Chronic Care Innovations, Inc.

Microlife

More Information

No publications provided

Responsible Party:	Capella University ( Scott McDoniel )
Study ID Numbers:	C41 # 001
Study First Received:	February 19, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00624598 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Vascular Diseases

Nutrition Disorders
Overweight
Overnutrition
Hypertension

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Vascular Diseases
Nutrition Disorders

Overweight
Overnutrition
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 04, 2009