Gestational DiabetesPRIDENCT01296516
Postpartum Weight Loss and Exercise (PRIDE)
A study testing Non-intervention group, Face to face and Telehelath Group in people with Gestational Diabetes and Glucose Intolerance, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Glucose Intolerance
- What is being tested?
- Non-intervention group, Face to face and Telehelath Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria:
- Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy
- English-speaking
Who cannot join
- Women enrolled in COPSS-GDM will be excluded if they met the following criteria:
- Medical Exclusion Criteria
- History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
- Regular use of medications for weight control or psychosis
- Current use of medication to treat diabetes Psychiatric and Behavioral Exclusion Criteria
- History or clinical manifestation of any eating disorder
Show all 10Show fewer
- Smoking
- History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years Other Exclusion Criteria
- Pregnancy or pregnancy planned during the coming year
- Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise
The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.
Read the detailed description
The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will:
- decrease body weight and
- reduce the rate of metabolic abnormalities, 12 months after delivery
- Conditions
- Gestational Diabetes, Glucose Intolerance
- Being tested
- Non-intervention group, Face to face, Telehelath Group
- Keywords
- Women, Postpartum, GDM
- Medical subject headings
- Diabetes, Gestational, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intervention groupBehavioural
Also called Placebo
A pedometer and written material on a healthy lifestyle.
Face to faceBehavioural
Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.
Telehelath GroupBehavioural
Also called Trestletree
Participants will speak to Trestletree personnel once a week via phone.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | A group matched for age and BMI will be selected to serve as control subjects in this study. Receives: Behavioral: Non-intervention group |
| Face-to-face group | Active comparator | Participants randomized to the face-to-face intervention will attend motivational meetings held once per week in Phase I and biweekly in Phase II. Behavioral sessions will be led by a trained interventionist and will take place at Pennington Biomedical Research Center. Receives: Behavioral: Face to face |
| Telehealth Group | Active comparator | Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system. Receives: Behavioral: Telehelath Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of glucose intolerance
To examine the incidence of glucose abnormalities (impaired fasting glucose, impaired glucose tolerance, type 2 diabetes) and health outcomes (changes in body fat, waist circumference and blood lipids)in women with a history of gestational diabetes, 12 months postpartum.
Measured: 8 Months
Secondary outcomes (1)
Weight loss
Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- THE C.B. AND IRENE PENNINGTON FOUNDATION
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M. Redman, PhD, Principal investigator, Pennington Biomedical Research CenterKaren Elkind-Hirsh, PhD, Study director, Womans' Research HospitalCatherine Chamagne, PhD, Study chair, Pennington Biomedical Research CenterTimothy S. Church, MD, MPH, PhD, Study chair, Pennington Biomedical Research CenterEric Ravussin, PhD, Study chair, Pennington Biomedical Reserach Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296516
- Sponsor's protocol ID
- PBRC 10041
- Acronym
- PRIDE
- Status last verified
- Aug 2021
- First submitted
- 14 Feb 2011
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise
- ClinicalTrials.gov ID
- NCT01296516
- Acronym / sponsor ID
- PRIDE / PBRC 10041
- Conditions
- Gestational Diabetes, Glucose Intolerance
- Keywords
- Women, Postpartum, GDM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- THE C.B. AND IRENE PENNINGTON FOUNDATION
- Study start
- Feb 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Feb 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.
The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.
Detailed description
The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will:
- decrease body weight and
- reduce the rate of metabolic abnormalities, 12 months after delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Non-intervention groupA group matched for age and BMI will be selected to serve as control subjects in this study. |
| Face-to-face group | Active comparator | Behavioral: Face to faceParticipants randomized to the face-to-face intervention will attend motivational meetings held once per week in Phase I and biweekly in Phase II. Behavioral sessions will be led by a trained interventionist and will take place at Pennington Biomedical Research Center. |
| Telehealth Group | Active comparator | Behavioral: Telehelath GroupParticipants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria:
Key exclusion criteria (10 listed)
- Medical Exclusion Criteria
- History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
- Regular use of medications for weight control or psychosis
- Current use of medication to treat diabetes Psychiatric and Behavioral Exclusion Criteria
- History or clinical manifestation of any eating disorder
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 |
|---|---|---|
| Non-intervention groupAlso: PlaceboA pedometer and written material on a healthy lifestyle. | Behavioural | Control Group |
| Face to faceMotivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist. | Behavioural | Face-to-face group |
| Telehelath GroupAlso: TrestletreeParticipants will speak to Trestletree personnel once a week via phone. | Behavioural | Telehealth Group |
Primary outcome
Incidence of glucose intolerance
Time frame: 8 Months
To examine the incidence of glucose abnormalities (impaired fasting glucose, impaired glucose tolerance, type 2 diabetes) and health outcomes (changes in body fat, waist circumference and blood lipids)in women with a history of gestational diabetes, 12 months postpartum.
1 secondary outcome
Weight loss
Time frame: 8 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 24 Aug 2021.
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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.
Leanne M. Redman, PhD principal investigator
Pennington Biomedical Research Center
Karen Elkind-Hirsh, PhD study director
Womans' Research Hospital
Catherine Chamagne, PhD study chair
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-intervention group, Face to face and Telehelath Group in people with Gestational Diabetes and Glucose Intolerance, run by Pennington Biomedical Research Center 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 3 inclusion and 10 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 Aug 2021. 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. 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?
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?
Incidence of glucose intolerance (time frame: 8 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 24 Aug 2021.