ObesityNCT00750022
Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care
A study testing Individualized IC treatment in people with Obesity and Hypertension, run by Colorado Center for Chronic Care Innovations, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Individualized IC treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI greater than 30 kg/m2
- 18-70 years of age
Who cannot join
- No participation in other weight loss efforts outside study.
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Center for Chronic Care Innovations
Westminster, Colorado, 80031
About this study
Official title: Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.
The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.
- Conditions
- Obesity, Hypertension
- Being tested
- Individualized IC treatment, Usual Care
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized IC treatmentBehavioural
Also called MedGem indirect Calorimeter
Individuals will receive IC measurement at baseline and three months. Nutrition and physical activity plan will be developed and adjusted from measured RMR and lifestyle.
Usual CareBehavioural
Also called MedGem indirect Calorimeter
Individuals will receive standard dietary plan. Women will receive 1200 Kcal/day and men will receive 1600 Kcal/day. Individuals will receive RMR measurement at three months. RMR information will be used to help improve eating behavior.
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | Not described Receives: Behavioral: Usual Care |
| A1 | Active comparator | Not described Receives: Behavioral: Individualized IC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bodyweight
Measured: Six Months
Secondary outcomes (4)
Psychobehavioral: Self-Efficacy
Measured: Six Months
Quality Life
Measured: Six Months
Blood Pressure
Measured: Six Months
Eating Behavior
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Chronic Care Innovations, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Microlife Medical Home Solutions, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750022
- Sponsor's protocol ID
- WCPC-0101
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2008
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
McDoniel SO, Wolskee P, Shen J. Treating obesity with a novel hand-held device, computer software program, and Internet technology in primary care: the SMART motivational trial. Patient Educ Couns. 2010 May;79(2):185-91. doi: 10.1016/j.pec.2009.07.034. Epub 2009 Aug 20.
PubMed 19699049
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.
- ClinicalTrials.gov ID
- NCT00750022
- Acronym / sponsor ID
- WCPC-0101
- Conditions
- Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Colorado Center for Chronic Care Innovations, Inc.University, hospital or other
- Collaborators
- Microlife Medical Home Solutions, Inc.
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Sep 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 feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Behavioral: Usual Care |
| A1 | Active comparator | Behavioral: Individualized IC treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI greater than 30 kg/m2
- 18-70 years of age
Key exclusion criteria (2 listed)
- No participation in other weight loss efforts outside study.
- Pregnant or lactating
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 |
|---|---|---|
| Individualized IC treatmentAlso: MedGem indirect CalorimeterIndividuals will receive IC measurement at baseline and three months. Nutrition and physical activity plan will be developed and adjusted from measured RMR and lifestyle. | Behavioural | A1 |
| Usual CareAlso: MedGem indirect CalorimeterIndividuals will receive standard dietary plan. Women will receive 1200 Kcal/day and men will receive 1600 Kcal/day. Individuals will receive RMR measurement at three months. RMR information will be used to help improve eating behavior. | Behavioural | E1 |
Primary outcome
Bodyweight
Time frame: Six Months
4 secondary outcomes
Psychobehavioral: Self-Efficacy
Time frame: Six Months
Quality Life
Time frame: Six Months
Blood Pressure
Time frame: Six Months
Eating Behavior
Time frame: Six Months
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 21 Sep 2009.
- Derived from this study: PubMed 19699049McDoniel SO, Wolskee P, Shen J. Treating obesity with a novel hand-held device, computer software program, and Internet technology in primary care: the SMART motivational trial. Patient Educ Couns. 2010 May;79(2):185-91. doi: 10.1016/j.pec.2009.07.034. Epub 2009 Aug 20.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized IC treatment in people with Obesity and Hypertension, run by Colorado Center for Chronic Care Innovations, Inc. at 1 site 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 2 inclusion and 2 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 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Bodyweight (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750022, which also lists 1 linked publication.
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 21 Sep 2009.