ObesityPRSNCT03192475
The Pitt Retiree Study: A Diabetes Prevention Program for Medicare Eligible Older Adults
A study testing GLB plus phone contacts and GLB plus newsletter contacts in people with Obesity and Cardiovascular Risk Factor, run by University of Pittsburgh.
Trial summary
The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12 month outcome data (with a no treatment follow-up assessment at 24 months) to help determine whether a continued contact group… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Risk Factor, Eating Behavior
- What is being tested?
- GLB plus phone contacts and GLB plus newsletter contacts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2013to 26 May 2017
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women, ages 65-80, with a BMI ≥ 27 and at least one of the following additional risk factors will be included: 1) Large waist circumference (> 40 inches men, >35 inches women) 2) hypertension or taking hypertension medication; 3) elevated lipids or taking medication for lipids or triglycerides 4) pre-diabetes (fasting glucose ≥ 100 mg/dL and < 126 mg/DL OR 5) or a score of 15 on the American Diabetes Association (ADA) risk test.
- All study participants must have access to a telephone (including appropriate assistive devices if there are hearing impairments) and be able to read at the 6th grade level.
Who cannot join
- Individuals who report that they have been diagnosed by their doctor with diabetes or that they are taking any medicines used to treat diabetes
- lack of physician clearance for exercise participation before the 4th session
- a weight loss of 4.5 kgs or more in the past six months (to rule out unintentional weight loss that may be an indicator of current or incipient physical illness)
- current use of weight loss medications
- unable to attend at least 75% of the GLB 12-session program or are unwilling to self-monitor food, activity and weight as prescribed will be excluded and encouraged to consider joining in subsequent years.
- Excluded individuals are referred to other clinical resources as appropriate.
About this study
Official title: Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12 month outcome data (with a no treatment follow-up assessment at 24 months) to help determine whether a continued contact group telephone intervention is feasible and effective in enhancing health outcomes and physical functional ability in high risk adults (aged 65-80) with obesity and cardiometabolic risk factors .
Read the detailed description
There is substantial evidence that overweight and obesity during late life (≥ 65 years of age) confers significant risk for type 2 diabetes and co-morbid conditions. Thus, there is growing concern about the public health consequences of increased incidence of type 2 diabetes in an aging United States population. Studies with high risk samples have shown that lifestyle interventions significantly reduce diabetes risk and that elders are particularly responsive, showing better weight loss and lower rates of diabetes development in comparison to younger individuals. However, although there have been program dissemination studies with mixed-age adult cohorts, few studies have focused specifically on persons ≥ 65 years of age or addressed the challenges of identifying workable platforms for delivering prevention programs to older adults. This application is based on the premise that offering an evidence-based lifestyle intervention to reduce risk for type 2 diabetes to retirees during the annual Medicare enrollment process presents an innovative, practical opportunity to reach eligible, high-risk adults. If shown to be feasible and effective, this program has strong potential for public health impact and medical cost-containment. Further, although clinical studies have emphasized the importance of continued contact over time in helping individuals extend the benefits of lifestyle interventions, there are no dissemination studies of which we are aware that have systematically documented the impact of continued monthly contacts after the initial intervention period. Thus, the overall aims of this application are to: 1. examine the feasibility and effectiveness of implementing the Group Lifestyle Balance 12-session program (GLB-12), an evidence-supported prevention program to mitigate diabetes risk, as part of the Medicare benefit offered to high risk retirees at a large public university, and; 2. evaluate the utility of continued telephone contact in enhancing treatment outcome at 12-months from baseline. Eligible participants will be 320 adults without diabetes, aged 65-80, with a BMI ≥ 27 and at least one additional cardiometabolic risk factor. All participants will receive the GLB-12 and then will be randomized to one of two continued contact protocols for the remaining one year of intervention, 8-sessions of continued small group contact by telephone (GLB-12 plus 8TC) or a newsletter control condition (GLB-12 plus NC). Program feasibility will be assessed by reporting enrollment, adherence and session completion rates, and satisfaction ratings in this delivery context. Effectiveness of the GLB-12 will be documented by reporting mean percent weight loss and the proportion of participants meeting ≥ 5% weight loss, a commonly accepted benchmark in translation studies known to be associated with favorable cardiometabolic outcomes at month 4. It also is hypothesized that GLB-12 plus 8TC, when compared to GLB-12 plus NC will be associated with more favorable anthropometric (weight, waist), cardiometabolic (glucose, blood pressure, lipid), physical function (chair stand, balance, gait speed) and health related quality of life outcomes at months 12 and 24. Finally, exploratory analyses will document program costs and program impact on medical utilization.
- Conditions
- Obesity, Cardiovascular Risk Factor, Eating Behavior, Diet Modification, Physical Activity, Quality of Life
- Being tested
- GLB plus phone contacts, GLB plus newsletter contacts
- Medical subject headings
- Obesity, Feeding Behavior, Motor Activity, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLB plus phone contactsBehavioural
GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving.
GLB plus newsletter contactsBehavioural
GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only.
| Study group | Role | What they receive |
|---|---|---|
| Group Lifestyle Balance plus phone contacts | Active comparator | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months Receives: Behavioral: GLB plus phone contacts |
| Group Lifestyle Balance plus newsletter contacts | Placebo comparator | Group Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. Receives: Behavioral: GLB plus newsletter contacts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bodyweight
Bodyweight of participant.
Measured: Change from baseline bodyweight at 12-months
Secondary outcomes (14)
Change in Waist Circumference
Waist circumference measured with a spring-loaded tape measure.
Measured: Change from baseline circumference at 12-months
Change in Fasting Total Cholesterol
Total cholesterol (mg/dl) measured by finger-stick blood sample
Measured: Change from baseline level at 12-months
Change in Fasting High-Density Lipoprotein (HDL) Cholesterol
HDL-cholesterol (mg/dl) measured by finger-stick blood sample
Measured: Change from baseline level at 12-months
Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol
LDL-cholesterol (mg/dl) measured by finger-stick blood sample
Measured: Change from baseline level at 12-months
Change in Fasting Triglycerides
Triglycerides (mg/dl) measured by fasting finger-stick sample
Measured: Change from baseline level at 12-months
Change in Fasting Glucose
Fasting glucose (mg/dl) measured by finger-stick sample
Measured: Change from baseline level at 12-months
Change in Systolic Blood Pressure
Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
Measured: Change from baseline level at 12-months
Change in Diastolic Blood Pressure (mmHg)
Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)
Measured: Change from baseline value at 12 months
Change in Physical Function Performance Battery
Short Physical Performance Battery (SPPB) total score (0-12) includes three function tests (each scored 0-4) and summed.
The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands. Higher score indicates better physical function.
Measured: Change from baseline score at 12-months
Change in Physical Activity Minutes/Week Using All CHAMPS Items
Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults
Measured: Change from baseline minutes/week at 12-months
Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week
Stanford Brief Physical Activity categorical measure:
Queries amount and intensity of typical weekly activities over the past month.
- most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month.
- most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home.
- at least 3 times per week reports moderate activity such as brisk walking for 15-20 minutes or more, or at least 45-60 minutes of heavy home and yard chores.
- at least 3 times per week reports a regular program of moderate-vigorous intensity physical activities, or a regular program of fitness for 30 minutes or more, or active games like handball or tennis, or heavy home and yard chores for 60-minutes or more.
Participants that endorse items 3 or 4 were considered to have achieved 3 or more days of moderate intensity physical activities per week.
Measured: percentage reporting higher intensity level activities 3 times per week or more at 12 months
Change in Health Related Quality of Life-physical Component Summary Score
Short-form 12-item health status questionnaire produces two scores: a physical component summary score and a mental component summary score. Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10.
Measured: Change from baseline score at 12-months
Change in Nutrition
Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.
Measured: change from baseline score at 12-months
Change in Mood
Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)
Measured: change from baseline score at 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start28 Jan 2013
- Primary completion26 May 2017
- Study completion26 May 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An initial (non-randomized) translational Group Lifestyle Balance (GLB) in person, lifestyle intervention designed to mitigate cardiometabolic risk in older adults is delivered to all participants between 0 and 4-months. Subsequently, one-half of the enrolled sample is randomized to either (1) 8-group telephone contacts (8-TC) for the remainder of 12-months; the other one-half is randomized to a newsletter control condition (NC) during this time period.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Venditti, University of Pittsburgh
- Investigators
- Elizabeth M Venditti, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192475
- Sponsor's protocol ID
- PRO12050022
- Acronym
- PRS
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2017
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the time of this R18 application in 2011 and resubmission and funding in 2012, a formal data sharing plan was neither required nor proposed. However, I will share final IPD with interested colleagues (including post-doctoral students and junior faculty, co-investigators at my institution across several departments including Medicine, Psychiatry, Epidemiology/Public Health). All data is de-identified per the original Data Safety and Monitoring Plan. All safeguards will be taken to ensure confidentiality and privacy of participants. I will not place limits on questions or methods of those sharing data files and only require that the Pitt Retiree Study participants and primary manuscripts resulting from this work, be acknowledged on all abstracts and manuscript publications resulting from the final data set.
Publications
Venditti EM, Marcus MD, Miller RG, Arena VC, Greenspan SL, Rockette-Wagner B. Group Lifestyle Phone Maintenance for Weight, Health, and Physical Function in Adults Aged 65-80 Years: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Jan 18;76(2):352-360. doi: 10.1093/gerona/glaa229.
PubMed 32918078
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
- ClinicalTrials.gov ID
- NCT03192475
- Acronym / sponsor ID
- PRS / PRO12050022
- Conditions
- Obesity, Cardiovascular Risk Factor, Eating Behavior, Diet Modification, Physical Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 28 Jan 2013 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12 month outcome data (with a no treatment follow-up assessment at 24 months) to help determine whether a continued contact group telephone intervention is feasible and effective in enhancing health outcomes and physical functional ability in high risk adults (aged 65-80) with obesity and cardiometabolic risk factors .
Detailed description
There is substantial evidence that overweight and obesity during late life (≥ 65 years of age) confers significant risk for type 2 diabetes and co-morbid conditions. Thus, there is growing concern about the public health consequences of increased incidence of type 2 diabetes in an aging United States population. Studies with high risk samples have shown that lifestyle interventions significantly reduce diabetes risk and that elders are particularly responsive, showing better weight loss and lower rates of diabetes development in comparison to younger individuals. However, although there have been program dissemination studies with mixed-age adult cohorts, few studies have focused specifically on persons ≥ 65 years of age or addressed the challenges of identifying workable platforms for delivering prevention programs to older adults. This application is based on the premise that offering an evidence-based lifestyle intervention to reduce risk for type 2 diabetes to retirees during the annual Medicare enrollment process presents an innovative, practical opportunity to reach eligible, high-risk adults. If shown to be feasible and effective, this program has strong potential for public health impact and medical cost-containment. Further, although clinical studies have emphasized the importance of continued contact over time in helping individuals extend the benefits of lifestyle interventions, there are no dissemination studies of which we are aware that have systematically documented the impact of continued monthly contacts after the initial intervention period. Thus, the overall aims of this application are to: 1. examine the feasibility and effectiveness of implementing the Group Lifestyle Balance 12-session program (GLB-12), an evidence-supported prevention program to mitigate diabetes risk, as part of the Medicare benefit offered to high risk retirees at a large public university, and; 2. evaluate the utility of continued telephone contact in enhancing treatment outcome at 12-months from baseline. Eligible participants will be 320 adults without diabetes, aged 65-80, with a BMI ≥ 27 and at least one additional cardiometabolic risk factor. All participants will receive the GLB-12 and then will be randomized to one of two continued contact protocols for the remaining one year of intervention, 8-sessions of continued small group contact by telephone (GLB-12 plus 8TC) or a newsletter control condition (GLB-12 plus NC). Program feasibility will be assessed by reporting enrollment, adherence and session completion rates, and satisfaction ratings in this delivery context. Effectiveness of the GLB-12 will be documented by reporting mean percent weight loss and the proportion of participants meeting ≥ 5% weight loss, a commonly accepted benchmark in translation studies known to be associated with favorable cardiometabolic outcomes at month 4. It also is hypothesized that GLB-12 plus 8TC, when compared to GLB-12 plus NC will be associated with more favorable anthropometric (weight, waist), cardiometabolic (glucose, blood pressure, lipid), physical function (chair stand, balance, gait speed) and health related quality of life outcomes at months 12 and 24. Finally, exploratory analyses will document program costs and program impact on medical utilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An initial (non-randomized) translational Group Lifestyle Balance (GLB) in person, lifestyle intervention designed to mitigate cardiometabolic risk in older adults is delivered to all participants between 0 and 4-months. Subsequently, one-half of the enrolled sample is randomized to either (1) 8-group telephone contacts (8-TC) for the remainder of 12-months; the other one-half is randomized to a newsletter control condition (NC) during this time period.
| Arm | Type | Receives |
|---|---|---|
| Group Lifestyle Balance plus phone contacts | Active comparator | Behavioral: GLB plus phone contactsGroup Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using an in-person group format. The active comparator receives 8 additional sessions of group interactive telephone contact delivered from 5-12 months |
| Group Lifestyle Balance plus newsletter contacts | Placebo comparator | Behavioral: GLB plus newsletter contactsGroup Lifestyle Balance is the core behavioral lifestyle intervention delivered from 0-4 months using in-person group format. The placebo comparator receives 4 additional educational newsletters delivered from 5-12 months. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women, ages 65-80, with a BMI ≥ 27 and at least one of the following additional risk factors will be included: 1) Large waist circumference (> 40 inches men, >35 inches women) 2) hypertension or taking hypertension medication; 3) elevated lipids or taking medication for lipids or triglycerides 4) pre-diabetes (fasting glucose ≥ 100 mg/dL and < 126 mg/DL OR 5) or a score of 15 on the American Diabetes Association (ADA) risk test.
- All study participants must have access to a telephone (including appropriate assistive devices if there are hearing impairments) and be able to read at the 6th grade level.
Key exclusion criteria (6 listed)
- Individuals who report that they have been diagnosed by their doctor with diabetes or that they are taking any medicines used to treat diabetes
- lack of physician clearance for exercise participation before the 4th session
- a weight loss of 4.5 kgs or more in the past six months (to rule out unintentional weight loss that may be an indicator of current or incipient physical illness)
- current use of weight loss medications
- unable to attend at least 75% of the GLB 12-session program or are unwilling to self-monitor food, activity and weight as prescribed will be excluded and encouraged to consider joining in subsequent years.
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 |
|---|---|---|
| GLB plus phone contactsGLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving. | Behavioural | Group Lifestyle Balance plus phone contacts |
| GLB plus newsletter contactsGLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only. | Behavioural | Group Lifestyle Balance plus newsletter contacts |
Primary outcome
Change in Bodyweight
Time frame: Change from baseline bodyweight at 12-months
Bodyweight of participant.
14 secondary outcomes
Change in Waist Circumference
Time frame: Change from baseline circumference at 12-months
Change in Fasting Total Cholesterol
Time frame: Change from baseline level at 12-months
Change in Fasting High-Density Lipoprotein (HDL) Cholesterol
Time frame: Change from baseline level at 12-months
Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol
Time frame: Change from baseline level at 12-months
Change in Fasting Triglycerides
Time frame: Change from baseline level at 12-months
Change in Fasting Glucose
Time frame: Change from baseline level at 12-months
Change in Systolic Blood Pressure
Time frame: Change from baseline level at 12-months
Change in Diastolic Blood Pressure (mmHg)
Time frame: Change from baseline value at 12 months
Change in Physical Function Performance Battery
Time frame: Change from baseline score at 12-months
Change in Physical Activity Minutes/Week Using All CHAMPS Items
Time frame: Change from baseline minutes/week at 12-months
Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week
Time frame: percentage reporting higher intensity level activities 3 times per week or more at 12 months
Change in Health Related Quality of Life-physical Component Summary Score
Time frame: Change from baseline score at 12-months
Change in Nutrition
Time frame: change from baseline score at 12-months
Change in Mood
Time frame: change from baseline score at 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32918078Venditti EM, Marcus MD, Miller RG, Arena VC, Greenspan SL, Rockette-Wagner B. Group Lifestyle Phone Maintenance for Weight, Health, and Physical Function in Adults Aged 65-80 Years: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Jan 18;76(2):352-360. doi: 10.1093/gerona/glaa229.
- Individual participant dataSharing planned: Yes. At the time of this R18 application in 2011 and resubmission and funding in 2012, a formal data sharing plan was neither required nor proposed. However, I will share final IPD with interested colleagues (including post-doctoral students and junior faculty, co-investigators at my institution across several departments including Medicine, Psychiatry, Epidemiology/Public Health). All data is de-identified per the original Data Safety and Monitoring Plan. All safeguards will be taken to ensure confidentiality and privacy of participants. I will not place limits on questions or methods of those sharing data files and only require that the Pitt Retiree Study participants and primary manuscripts resulting from this work, be acknowledged on all abstracts and manuscript publications resulting from the final data set.
Related trials for Obesity
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Elizabeth M Venditti, PhD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing GLB plus phone contacts and GLB plus newsletter contacts in people with Obesity and Cardiovascular Risk Factor, run by University of Pittsburgh.
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 6 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 24 Apr 2024. 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. Some participants in this study may receive a placebo. 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 13 Nov 2019). 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?
Change in Bodyweight (time frame: Change from baseline bodyweight at 12-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 NCT03192475, 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 24 Apr 2024.