ObesityWCPCNCT00624598
The Short-Term Effect of a Technology Driven Weight Control (SMART) Program for Obese Adults
A study testing SMART in people with Obesity and Hypertension, run by Colorado Center for Chronic Care Innovations, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- SMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Westmed Family Healthcare
Westminster, Colorado, 80031
Westminster Medical Center
Westminster, Colorado, 80031
About this study
Official title: 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.
- Conditions
- Obesity, Hypertension
- Being tested
- SMART
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTBehavioural
Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Individuals receiving a technology-based weight reduction program will not lose significantly more weight compared to control group.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Chronic Care Innovations, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Microlife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624598
- Sponsor's protocol ID
- C41 # 001
- Acronym
- WCPC
- Status last verified
- Sep 2008
- First submitted
- 19 Feb 2008
- Last updated
- 17 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Integrating RMR Technology and Email Counseling in a PCP Office.
- ClinicalTrials.gov ID
- NCT00624598
- Acronym / sponsor ID
- WCPC / C41 # 001
- Conditions
- Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Colorado Center for Chronic Care Innovations, Inc.University, hospital or other
- Collaborators
- Microlife
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART Group | Experimental | Behavioral: SMARTThe 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. |
| Usual Care | Active comparator | Behavioral: SMARTStandard 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMARTUse of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise. | Behavioural | SMART Group, Usual Care |
Primary outcome
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
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
Individuals receiving a technology-based weight reduction program will not lose significantly more weight compared to control group.
Time frame: 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).
Time frame: 10 Weeks
2 secondary outcomes
Individuals receiving a technology-based weight reduction program will not significantly improve weight quality of life compared to control group.
Time frame: 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).
Time frame: 10 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART in people with Obesity and Hypertension, run by Colorado Center for Chronic Care Innovations, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2008.