Clinical trial NCT00624598: The Short-Term Effect of a Technology Driven Weight Control (SMART) Program for Obese Adults
Official title: Phase I Study of Integrating RMR Technology and Email Counseling in a PCP Office.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Lead sponsor: Colorado Center for Chronic Care Innovations, Inc.
Sponsor class: OTHER
Collaborators: name: Microlife
First posted: 2008-02-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 10 weeks
measure: 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.
timeFrame: 10 weeks
measure: Individuals receiving a technology-based weight reduction program will not lose significantly more weight compared to control group.
timeFrame: 10 weeks
measure: 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).
timeFrame: 10 Weeks
Secondary outcomes:
measure: Individuals receiving a technology-based weight reduction program will not significantly improve weight quality of life compared to control group.
timeFrame: 10 weeks
measure: 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).
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Westminster
country: United States
facility: Westmed Family Healthcare
state: Colorado
city: Westminster
country: United States
facility: Westminster Medical Center
state: Colorado
Study officials:
References: