Gestational DiabetesAPPLESNCT01489163
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
A study testing Lifestyle Counseling in people with Gestational Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
- Pregnancy complicated by high glucose levels starting November 2011
Who cannot join
- Recognized DM prior to pregnancy
- Uncontrolled hypertension during pregnancy
- Severe active thyroid disease during pregnancy
- Severe diseases of the cardio-pulmonary system
- Diagnosis of a severe psychiatric disorder
- Diagnosis of cancer
Show all 9Show fewer
- Conditions that lead to diet changes
- Addiction to alcohol or illegal drugs
- Current corticosteroid medicine use
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Research Northern California
Oakland, California, 94612
About this study
Official title: Translational Diabetes Prevention in GDM
The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.
- Conditions
- Gestational Diabetes
- Being tested
- Lifestyle Counseling
- Keywords
- Gestational Diabetes, Weight Loss, Physical Activity, Pregnancy, Postpartum, Intervention
- Medical subject headings
- Diabetes, Gestational, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling | Experimental | Not described Receives: Behavioral: Lifestyle Counseling |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum body weight
Measured: through 24 months postpartum
Secondary outcomes (4)
the proportion of women who reach body weight goals
Measured: through 24 months postpartum
percent of calories from fat
Measured: through 24 months postpartum
time spent in physical activity (PA) by intensity
Measured: through 24 months postpartum
postpartum glycemia
Measured: through 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2015
- 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.
- More trials run by Kaiser PermanenteThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assiamira Ferrara, MD, PhD, Principal investigator, Kaiser Permanente Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489163
- Sponsor's protocol ID
- CN-03AFerr-02-H
- Acronym
- APPLES
- Status last verified
- Feb 2019
- First submitted
- 7 Dec 2011
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Diabetes Prevention in GDM
- ClinicalTrials.gov ID
- NCT01489163
- Acronym / sponsor ID
- APPLES / CN-03AFerr-02-H
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, Weight Loss, Physical Activity, Pregnancy, Postpartum, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 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.
The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling | Experimental | Behavioral: Lifestyle Counseling |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
- Pregnancy complicated by high glucose levels starting November 2011
Key exclusion criteria (9 listed)
- Recognized DM prior to pregnancy
- Uncontrolled hypertension during pregnancy
- Severe active thyroid disease during pregnancy
- Severe diseases of the cardio-pulmonary system
- Diagnosis of a severe psychiatric 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 |
|---|---|---|
| Lifestyle CounselingThe Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum. | Behavioural | Lifestyle Counseling |
Primary outcome
postpartum body weight
Time frame: through 24 months postpartum
4 secondary outcomes
the proportion of women who reach body weight goals
Time frame: through 24 months postpartum
percent of calories from fat
Time frame: through 24 months postpartum
time spent in physical activity (PA) by intensity
Time frame: through 24 months postpartum
postpartum glycemia
Time frame: through 24 months postpartum
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 4 Feb 2019.
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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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.
Assiamira Ferrara, MD, PhD principal investigator
Kaiser Permanente Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counseling in people with Gestational Diabetes, run by Kaiser Permanente 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 2 inclusion and 9 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 4 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 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. 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?
postpartum body weight (time frame: through 24 months postpartum). 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 4 Feb 2019.