Weight GainH42/H4UNCT03551054
Healthy for Two, Healthy for You
A study testing Healthy for Two, Healthy for You and Health Education in people with Weight Gain and Pregnancy Related, run by Johns Hopkins University.
Trial summary
Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Pregnancy Related
- What is being tested?
- Healthy for Two, Healthy for You and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2016to 27 Mar 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers:
- BMI >= 18.5 kg/m2 at time of eligibility screening
- Age >=18
- Able to provide informed consent
- 12 weeks gestation or earlier
- English speaking
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- Insurance type
- Willing to provide address and >=2 contact people
- Consistent use of a personal smartphone and willingness to use for health behavior tracking as part of the study
- Patient at a participating prenatal clinical site
- Access to internet (including public library and smartphone)
- Demonstrated ability to track caloric intake for 4 days
- Singleton pregnancy
- Infants:
- Born during Mother's enrollment in study
Who cannot join
- • Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation)
- Multiple fetuses
- Prior history of severe preeclampsia, pre-term birth (before 32 weeks gestation)
- Prior history of or current diagnosis of incompetent cervix
- Poorly controlled blood pressure (>160/100)
- Unable to walk 1 block without pain, shortness of breath
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- Serious medication condition hindering use of recommendations for pregnancy weight gain
- Not cleared by study's maternal-fetal medicine or treating obstetrician
- Planning to relocate from areas in next 2 years
- Psychiatric or substance use related hospitalization in past 1 year
- (There is no exclusion criteria for the infants)
About this study
Official title: Healthy for Two, Healthy for You: A Pilot Health Coaching Intervention for Pregnant Women
Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.
Read the detailed description
Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities. Maternal obesity is linked with adverse perinatal outcomes, including gestational diabetes and preeclampsia, as well as longer-term health problems such as obesity in offspring and maternal cardiovascular disease. Pregnancy provides a unique opportunity to engage women in improving their health behaviors because women are motivated to protect the health of their babies and have frequent interactions with the healthcare system. Advances in behavioral weight management and obesity prevention have not yet been translated into real-world prenatal care settings. Our team was recently supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Nutrition and Obesity Research Center Pilot and Feasibility program to adapt an evidence-based telephonic health coaching program for pregnant women. Investigators conducted 20 in-depth interviews with patients and providers to gain valuable feedback to inform the intervention design and delivery, and have put together a multi-disciplinary team to adapt the intervention. Investiagtors developed the intervention specific for pregnancy and postpartum based on this feedback and are testing the intervention, Healthy for Two / Healthy for You, to assess feasibility and acceptability.
- Conditions
- Weight Gain, Pregnancy Related
- Being tested
- Healthy for Two, Healthy for You, Health Education
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy for Two, Healthy for YouBehavioural
Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.
Health EducationBehavioural
Also called Single health education visit
| Study group | Role | What they receive |
|---|---|---|
| Healthy for Two, Healthy for You | Experimental | Remotely delivered behavioral health coaching in pregnancy and postpartum Receives: Behavioral: Healthy for Two, Healthy for You |
| Pregnancy Health Education | Active comparator | Single health education visit with study staff member Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation.
Measured: At 37 weeks gestation
Secondary outcomes (1)
Postpartum weight retention
Postpartum weight retention is calculated as weight, in pounds, recorded at 3 months after delivery minus the weight recorded at baseline (by 14 weeks gestation).
Measured: At 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start22 Jul 2016
- Primary completion30 Jun 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Parallel randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Mid-Atlantic Nutrition Obesity Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551054
- Sponsor's protocol ID
- IRB00084709
- Acronym
- H42/H4U
- Status last verified
- May 2018
- First submitted
- 29 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy for Two, Healthy for You: A Pilot Health Coaching Intervention for Pregnant Women
- ClinicalTrials.gov ID
- NCT03551054
- Acronym / sponsor ID
- H42/H4U / IRB00084709
- Conditions
- Weight Gain, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Mid-Atlantic Nutrition Obesity Research Center
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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.
Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.
Detailed description
Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities. Maternal obesity is linked with adverse perinatal outcomes, including gestational diabetes and preeclampsia, as well as longer-term health problems such as obesity in offspring and maternal cardiovascular disease. Pregnancy provides a unique opportunity to engage women in improving their health behaviors because women are motivated to protect the health of their babies and have frequent interactions with the healthcare system. Advances in behavioral weight management and obesity prevention have not yet been translated into real-world prenatal care settings. Our team was recently supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Nutrition and Obesity Research Center Pilot and Feasibility program to adapt an evidence-based telephonic health coaching program for pregnant women. Investigators conducted 20 in-depth interviews with patients and providers to gain valuable feedback to inform the intervention design and delivery, and have put together a multi-disciplinary team to adapt the intervention. Investiagtors developed the intervention specific for pregnancy and postpartum based on this feedback and are testing the intervention, Healthy for Two / Healthy for You, to assess feasibility and acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Healthy for Two, Healthy for You | Experimental | Behavioral: Healthy for Two, Healthy for YouRemotely delivered behavioral health coaching in pregnancy and postpartum |
| Pregnancy Health Education | Active comparator | Behavioral: Health EducationSingle health education visit with study staff member |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Mothers:
- Born during Mother's enrollment in study
Key exclusion criteria (11 listed)
- • Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation)
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 |
|---|---|---|
| Healthy for Two, Healthy for YouRemotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain. | Behavioural | Healthy for Two, Healthy for You |
| Health EducationAlso: Single health education visit | Behavioural | Pregnancy Health Education |
Primary outcome
Gestational weight gain
Time frame: At 37 weeks gestation
Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation.
1 secondary outcome
Postpartum weight retention
Time frame: At 3 months after delivery
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 11 Jun 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy for Two, Healthy for You and Health Education in people with Weight Gain and Pregnancy Related, run by Johns Hopkins 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 15 inclusion and 11 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 11 Jun 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?
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?
Gestational weight gain (time frame: At 37 weeks gestation). 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 11 Jun 2018.