OverweightNCT01492413
Impact of an Online Behavioral Weight Loss Program
A study testing online lifestyle counseling and a fortified diet beverage in people with Overweight and Obesity, run by Baylor College of Medicine at 3 sites in 2 countries.
Trial summary
This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC +… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- online lifestyle counseling and a fortified diet beverage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2008to Dec 2011
- 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
- Body Mass Index (BMI) of 25 to 40;
- age 18 to 65 years;
- blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
- caffeine intake 100-400 mg/d; and
- ability to participate in physical activity for a minimum of 150 min/week.
Who cannot join
- pregnancy, lactation or actively trying to become pregnant;
- medical illnesses or medications that could affect body weight;
- cigarette smokers;
- weight loss of 10 or more pounds in the last 3 months;
- fasting blood glucose greater than 126mg/dl;
- participation in a clinical research study that would conflict with the purpose of the current trial; and
- other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Behavioral Medicine Research Center
Houston, Texas, 77030
Temple University
Philadelphia, Pennsylvania
About this study
Official title: Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage
This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12 weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after 12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.
Read the detailed description
This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.
- Conditions
- Overweight, Obesity
- Being tested
- online lifestyle counseling and a fortified diet beverage
- Keywords
- Overweight, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online lifestyle counseling and a fortified diet beverageBehavioural
The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).
| Study group | Role | What they receive |
|---|---|---|
| Online basic lifestyle counseling (OBLI) | Experimental | Subjects receive one online informational class. Receives: Behavioral: online lifestyle counseling and a fortified diet beverage |
| Online lifestyle counseling (OLC) | Experimental | Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss. Receives: Behavioral: online lifestyle counseling and a fortified diet beverage |
| OBLI intervention plus a fortified diet beverage (BEV) | Experimental | Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage. Receives: Behavioral: online lifestyle counseling and a fortified diet beverage |
| OLC plus fortified diet beverage (BEV) | Experimental | Subjects receive OLC plus diet beverage (BEV). Receives: Behavioral: online lifestyle counseling and a fortified diet beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.
Measured: 12 weeks
Secondary outcomes (1)
DEXA-determined fat mass
Body fat percent is determined by DEXA using a whole body scanner.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Beverage Institute., Temple University, MRC Human Nutrition Research, National Development and Research Institutes, Inc.
- Responsible party
- Principal investigator, John P. Foreyt, Baylor College of Medicine
- Investigators
- John P Foreyt, Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492413
- Sponsor's protocol ID
- BI-001
- Status last verified
- Dec 2011
- First submitted
- 13 Dec 2011
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage
- ClinicalTrials.gov ID
- NCT01492413
- Acronym / sponsor ID
- BI-001
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Beverage Institute., Temple University, MRC Human Nutrition Research, National Development and Research Institutes, Inc.
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Dec 2011 (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.
This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12 weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after 12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.
Detailed description
This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Online basic lifestyle counseling (OBLI) | Experimental | Behavioral: online lifestyle counseling and a fortified diet beverageSubjects receive one online informational class. |
| Online lifestyle counseling (OLC) | Experimental | Behavioral: online lifestyle counseling and a fortified diet beverageSubjects receive 12 weekly online classes with a focus on behavior modification for weight loss. |
| OBLI intervention plus a fortified diet beverage (BEV) | Experimental | Behavioral: online lifestyle counseling and a fortified diet beverageSubjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage. |
| OLC plus fortified diet beverage (BEV) | Experimental | Behavioral: online lifestyle counseling and a fortified diet beverageSubjects receive OLC plus diet beverage (BEV). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) of 25 to 40;
- age 18 to 65 years;
- blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
- caffeine intake 100-400 mg/d; and
- ability to participate in physical activity for a minimum of 150 min/week.
Key exclusion criteria (7 listed)
- pregnancy, lactation or actively trying to become pregnant;
- medical illnesses or medications that could affect body weight;
- cigarette smokers;
- weight loss of 10 or more pounds in the last 3 months;
- fasting blood glucose greater than 126mg/dl;
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 |
|---|---|---|
| online lifestyle counseling and a fortified diet beverageThe fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg). | Behavioural | OBLI intervention plus a fortified diet beverage (BEV), OLC plus fortified diet beverage (BEV), Online basic lifestyle counseling (OBLI), Online lifestyle counseling (OLC) |
Primary outcome
body weight
Time frame: 12 weeks
Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.
1 secondary outcome
DEXA-determined fat mass
Time frame: 12 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 15 Dec 2011.
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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.
John P Foreyt, Ph.D. principal investigator
Baylor College of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online lifestyle counseling and a fortified diet beverage in people with Overweight and Obesity, run by Baylor College of Medicine at 3 sites in 2 countries.
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 5 inclusion and 7 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 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. 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?
body weight (time frame: 12 weeks). 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 15 Dec 2011.