NCT00624598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 17, 2008

Status Verified

September 1, 2008

Enrollment Period

6 months

First QC Date

February 19, 2008

Last Update Submit

September 15, 2008

Conditions

ObesityHypertension

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

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

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

Interventions

SMARTBEHAVIORAL

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

SMART GroupUsual Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Westmed Family Healthcare

Westminster, Colorado, 80031, United States

Location

Westminster Medical Center

Westminster, Colorado, 80031, United States

Location

MeSH Terms

Conditions

ObesityHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 27, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

September 17, 2008

Record last verified: 2008-09

Locations

US(2)