ObesityNCT00749606
Study to Promote Weight Loss in Primary Care Practices
A study testing Individual telephone intervention and Group telephone intervention in people with Obesity, run by State University of New York - Upstate Medical University.
Trial summary
The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Individual telephone intervention and Group telephone intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese
- Metabolic syndrome
- Read and write English
- Planning to stay in treatment with their PCP for the next 3 years
- On stable doses of medications for chronic diseases such as hypothyroidism for 3 years
Who cannot join
- Unstable health
- Diabetes mellitus
- Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.
About this study
Official title: Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program
The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.
Read the detailed description
Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.
- Conditions
- Obesity
- Being tested
- Individual telephone intervention, Group telephone intervention
- Keywords
- Obesity, Metabolic syndrome, Weight loss, Diabetes prevention
- Medical subject headings
- Obesity, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual telephone interventionBehavioural
Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
Group telephone interventionBehavioural
Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
| Study group | Role | What they receive |
|---|---|---|
| Individual Telephone Intervention | Experimental | Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. Receives: Behavioral: Individual telephone intervention |
| Group Telephone Intervention | Active comparator | Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. Receives: Behavioral: Group telephone intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight (kg)
Measured: baseline, 1, 2, 3 years
Secondary outcomes (6)
Blood Pressure
Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
Measured: baseline, 1, 2, 3 years
Fasting Lipid Panel
LDL-cholesterol (mg/dL)
Measured: baseline, 1, 2, 3 years
Fasting Glucose Level
Fasting glucose (mg/dL)
Measured: baseline, 1, 2, 3 years
Health Behaviors (Diet, Physical Activity)
National Cancer Institute Fat screener
Measured: baseline, 6 months, 1 and 2 years
SF-12 Physical Summary Score
The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).
Measured: baseline, 6 months, 1 and 2 years
International Physical Activity Questionnaire
Measure of physical activity is calculated as in mets/week
Measured: baseline, 6 months, 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJun 2009
- Primary completionOct 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Weinstock, State University of New York - Upstate Medical University
- Investigators
- Ruth S. Weinstock, MD PhD, Principal investigator, State University of New York - Upstate Medical UniversityPaula Trief, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749606
- Sponsor's protocol ID
- R18DK078553
- Other IDs
- R18DK078553
- Status last verified
- Feb 2018
- First submitted
- 5 Sep 2008
- Last updated
- 12 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weinstock RS, Trief PM, Cibula D, Morin PC, Delahanty LM. Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. J Gen Intern Med. 2013 Dec;28(12):1620-8. doi: 10.1007/s11606-013-2529-7. Epub 2013 Jul 11.
PubMed 23843020Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014 Dec;22(12):2532-8. doi: 10.1002/oby.20916. Epub 2014 Sep 24.
PubMed 25251749Trief PM, Weinstock RS, Cibula D, Delahanty LM. Sustained weight loss one year after group telephone intervention: 3-year results from the SHINE study. Diabetes Res Clin Pract. 2014 Dec;106(3):e74-8. doi: 10.1016/j.diabres.2014.09.032. Epub 2014 Oct 5.
PubMed 25451907
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT00749606
- Acronym / sponsor ID
- R18DK078553
- Conditions
- Obesity
- Keywords
- Obesity, Metabolic syndrome, Weight loss, Diabetes prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 5 Dec 2017
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 determine if primary care based, telephone-delivered weight loss interventions are effective.
Detailed description
Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Telephone Intervention | Experimental | Behavioral: Individual telephone interventionIndividually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. |
| Group Telephone Intervention | Active comparator | Behavioral: Group telephone interventionGroup education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obese
- Metabolic syndrome
- Read and write English
- Planning to stay in treatment with their PCP for the next 3 years
- On stable doses of medications for chronic diseases such as hypothyroidism for 3 years
Key exclusion criteria (3 listed)
- Unstable health
- Diabetes mellitus
- Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.
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 |
|---|---|---|
| Individual telephone interventionIndividually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. | Behavioural | Individual Telephone Intervention |
| Group telephone interventionGroup education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. | Behavioural | Group Telephone Intervention |
Primary outcome
Weight
Time frame: baseline, 1, 2, 3 years
Weight (kg)
6 secondary outcomes
Blood Pressure
Time frame: baseline, 1, 2, 3 years
Fasting Lipid Panel
Time frame: baseline, 1, 2, 3 years
Fasting Glucose Level
Time frame: baseline, 1, 2, 3 years
Health Behaviors (Diet, Physical Activity)
Time frame: baseline, 6 months, 1 and 2 years
SF-12 Physical Summary Score
Time frame: baseline, 6 months, 1 and 2 years
International Physical Activity Questionnaire
Time frame: baseline, 6 months, 1 and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23843020Weinstock RS, Trief PM, Cibula D, Morin PC, Delahanty LM. Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. J Gen Intern Med. 2013 Dec;28(12):1620-8. doi: 10.1007/s11606-013-2529-7. Epub 2013 Jul 11.
- Results publication: PubMed 25251749Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014 Dec;22(12):2532-8. doi: 10.1002/oby.20916. Epub 2014 Sep 24.
- Results publication: PubMed 25451907Trief PM, Weinstock RS, Cibula D, Delahanty LM. Sustained weight loss one year after group telephone intervention: 3-year results from the SHINE study. Diabetes Res Clin Pract. 2014 Dec;106(3):e74-8. doi: 10.1016/j.diabres.2014.09.032. Epub 2014 Oct 5.
- Weight Loss Success in Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study.Link provided by the sponsor.
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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.
Ruth S. Weinstock, MD PhD principal investigator
State University of New York - Upstate Medical University
Paula Trief, PhD principal investigator
State University of New York - Upstate Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Individual telephone intervention and Group telephone intervention in people with Obesity, run by State University of New York - Upstate Medical University.
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 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 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight (time frame: baseline, 1, 2, 3 years). 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 NCT00749606, which also lists 3 linked publications.
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 12 Feb 2018.