ObesityNCT01664026
Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors
A study testing Web-based lifestyle modification and Web-based lifestyle modification + in people with Obesity, run by Clínica Bazterrica at 1 site in Argentina.
Trial summary
To evaluate the effect of a 6-month web-based lifestyle modification program with and without telephone counseling versus usual care in obese patients with cardiovascular risk factors on: Weight Loss Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol; glucose and… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Web-based lifestyle modification and Web-based lifestyle modification +
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2012to Dec 2013
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 25-70 years of age
- Obese (BMI ≥ 30 kg/m2 and <40 kg/m2)
- At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i) Hypertension defined by a history of hypertension, treatment of hypertension or BP values >140/90 mmHg in two consecutive office visits ii) High cholesterol defined by an LDL-C ≥130 mg/dL and/or HDL-C <40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2 Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting glucose ≥126 mg/dL in two consecutive office visits
- Participant must be willing and able to provide written informed consent
- Participant must be willing and able to comply with study related procedures
- Participant must have access to Internet and e-mail
Who cannot join
- Stage 1 or 2 on Patient Activation Measures tool
- Weight change of more than 5 kg during the 3 months preceding the screening visit
- History of bariatric surgery
- Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L)
- Hemoglobin A1c at screening >8.5%
- Treatment of type 2 diabetes with insulin (except for history of intermittent acute use, no more than 2 weeks usage in previous 6 months)
Show all 15Show fewer
- Uncontrolled or inadequately controlled hypertension at the time of screening with blood pressure >160/100 mmHg
- Secondary hypertension
- Changes in lipid, blood pressure or diabetes modifying agents including introduction, change in dose or cessation in the 3 months prior to Screening Visit
- Personal history of coronary heart disease, congestive heart failure, serious arrhythmias and stroke
- Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
- Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study
- Presence of history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
- Use of any investigational agent (drug, biologic, device) within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support
To evaluate the effect of a 6-month web-based lifestyle modification program with and without telephone counseling versus usual care in obese patients with cardiovascular risk factors on:
- Weight Loss
- Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.
- Physical activity and eating habits
- Quality of life
- Conditions
- Obesity
- Being tested
- Web-based lifestyle modification, Web-based lifestyle modification +
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based lifestyle modificationBehavioural
Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.
Web-based lifestyle modification +Behavioural
Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care. |
| Web | Experimental | Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance. Receives: Behavioral: Web-based lifestyle modification |
| Web+ | Experimental | Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis. Receives: Behavioral: Web-based lifestyle modification + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from randomization to 6 months
Measured: 6 months
Secondary outcomes (5)
Changes in waist circumference
Measured: 6 months
Changes in blood pressure
Measured: 6 months
Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)
Measured: 6 months
Changes in glycemic parameters (glucose and hemoglobin A1c)
Measured: 6 months
Changes in C-reactive protein
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Lack of funds
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica Bazterrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo Angelino, Clínica Bazterrica
- Investigators
- Andres Digenio, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664026
- Sponsor's protocol ID
- PWeb123
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2012
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support
- ClinicalTrials.gov ID
- NCT01664026
- Acronym / sponsor ID
- PWeb123
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clínica BazterricaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 14 Aug 2012 (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.
To evaluate the effect of a 6-month web-based lifestyle modification program with and without telephone counseling versus usual care in obese patients with cardiovascular risk factors on:
- Weight Loss
- Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.
- Physical activity and eating habits
- Quality of life
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care. |
| Web | Experimental | Behavioral: Web-based lifestyle modificationAccess to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance. |
| Web+ | Experimental | Behavioral: Web-based lifestyle modification +Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 25-70 years of age
- Obese (BMI ≥ 30 kg/m2 and <40 kg/m2)
- At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i) Hypertension defined by a history of hypertension, treatment of hypertension or BP values >140/90 mmHg in two consecutive office visits ii) High cholesterol defined by an LDL-C ≥130 mg/dL and/or HDL-C <40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2 Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting glucose ≥126 mg/dL in two consecutive office visits
- Participant must be willing and able to provide written informed consent
- Participant must be willing and able to comply with study related procedures
Key exclusion criteria (15 listed)
- Stage 1 or 2 on Patient Activation Measures tool
- Weight change of more than 5 kg during the 3 months preceding the screening visit
- History of bariatric surgery
- Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L)
- Hemoglobin A1c at screening >8.5%
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 |
|---|---|---|
| Web-based lifestyle modificationAccess to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance. | Behavioural | Web |
| Web-based lifestyle modification +Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis. | Behavioural | Web+ |
Primary outcome
Change in body weight from randomization to 6 months
Time frame: 6 months
5 secondary outcomes
Changes in waist circumference
Time frame: 6 months
Changes in blood pressure
Time frame: 6 months
Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)
Time frame: 6 months
Changes in glycemic parameters (glucose and hemoglobin A1c)
Time frame: 6 months
Changes in C-reactive protein
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
Andres Digenio, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based lifestyle modification and Web-based lifestyle modification + in people with Obesity, run by Clínica Bazterrica at 1 site in Argentina.
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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 1 Feb 2019. 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 Argentina. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in body weight from randomization to 6 months (time frame: 6 months). 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 1 Feb 2019; AzTrials last refreshed its copy on 30 Oct 2026.