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

Phase I Study of Integrating RMR Technology and Email Counseling in a PCP Office.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity
• Intervention / Treatment: Behavioral: SMART

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	10 weeks
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.	10 weeks
Individuals receiving a technology-based weight reduction program will not lose significantly more weight compared to control group.	10 weeks
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).	10 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Individuals receiving a technology-based weight reduction program will not significantly improve weight quality of life compared to control group.	10 weeks
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).	10 Weeks

Collaborators and Investigators

• Sponsor: Colorado Center for Chronic Care Innovations, Inc.
• Collaborators: Microlife

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2008
• Last Update Submitted That Met QC Criteria: September 15, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: C41 # 001