ObesityHABITNCT03069690
Optimizing Health From Pregnancy Through One Year Postpartum
A study testing HABITpreg and HABITpost in people with Obesity and Pregnancy Related, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will evaluate the impact of different combinations of intervention as a function of gestational weight gain in pregnant woman. Participants will be randomized at two points during the study. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Obesity, Pregnancy Related
- What is being tested?
- HABITpreg and HABITpost
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 21 Jun 2024
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a prenatal BMI ≥ 25
- Are at or before 18 weeks and 4 days of gestation
- Are English speaking
- Have a singleton pregnancy
Who cannot join
- Multiple gestations
- Preexisting diabetes
- Previous bariatric surgery in the previous 3 years
- Use of medications known to affect weight (e.g., second generation antipsychotic medications, regular steroid use).
- Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimizing Health From Pregnancy Through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial (SMART) of Perinatal Lifestyle Interventions
This study will evaluate the impact of different combinations of intervention as a function of gestational weight gain in pregnant woman. Participants will be randomized at two points during the study. Participants will first be randomized at enrollment to receive study intervention during pregnancy or treatment as usual. Participants will also be randomized just before delivery to receive intervention postpartum or treatment as usual.
Read the detailed description
The perinatal period, from pregnancy through the first postpartum year, has important implications for women's health. Excessive gestational weight gain is linked to deleterious health outcomes; yet most women exceed guidelines established for gestational weight gain , particularly women who begin pregnancy overweight or obese. These women are likely to remain overweight or obese at one year postpartum even if gestational weight gain is within guidelines and pregnancy-related weight gain is lost postpartum. Efforts to mitigate the health risks related to perinatal overweight can have substantial benefits for women's longer-term obesity and cardiometabolic health. To date, interventions to minimize excessive gestational weight gain alone have had limited impact. Some women may require continued intervention in the postpartum period to achieve optimal weight management. Alternatively, intervention delivered only postpartum may be sufficient to achieve a healthier weight at one year postpartum. It also is important to adapt intervention as women's needs vary over the course of pregnancy and postpartum. Accordingly, this application proposes a sequential multiple assignment randomized trial (SMART) to determine the efficacy of different intervention sequences during pregnancy, postpartum, or both. This non-restricted SMART also will allow investigators to investigate the impact of different combinations of intervention as a function of gestational weight gain. The proposed SMART is innovative as the first effort to evaluate different sequences of intervention across the perinatal period to mitigate maternal health risk by one year postpartum.
Pregnant women (N=300), stratified by prenatal weight status (body mass index=25-29.9 vs. ≥30) will be enrolled at entry into prenatal care and randomized initially to intervention that addresses the challenges of weight and self-regulation during pregnancy, Health and Behaviors in Transition (HABITpreg), or an educationally-enhanced treatment as usual (TAUpreg). At delivery, women will be re-randomized to a postpartum self-regulation intervention (HABITpost) or educationally-enhanced treatment as usual (TAUpost). Women will complete assessments at a prenatal baseline, the end of pregnancy, and 6- and 12-months postpartum.
- Conditions
- Obesity, Pregnancy Related
- Being tested
- HABITpreg, HABITpost
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABITpregBehavioural
Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included.
Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020.
HABITpostBehavioural
Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues.
Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020.
| Study group | Role | What they receive |
|---|---|---|
| HABITpreg; TAUpost | Experimental | Participants will receive study intervention during pregnant and treatment as usual postpartum. Receives: Behavioral: HABITpreg |
| HABITpreg, HABITpost | Experimental | Participants will receive study intervention during pregnancy and study intervention during the postpartum period. Receives: Behavioral: HABITpreg; Behavioral: HABITpost |
| TAUpreg; HABITpost | Experimental | Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period. Receives: Behavioral: HABITpost |
| TAUpreg; TAUpost | No intervention | Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Weight
Maternal weight in lbs
Measured: Baseline and 1 year postpartum
Secondary outcomes (4)
Maternal Lipids
Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride).
Measured: Baseline and 1 year postpartum (T12)
Maternal Inflammatory Markers
Maternal inflammatory markers from blood analysis
Measured: Baseline and 1 year postpartum (T12)
Depressive Symptoms (EPDS)
Scores from the Edinburgh Postnatal Depression Scale (EPDS)
This scale is developed to assist health professionals in detecting mothers suffering from postpartum depression (PPD), consists of 10 short statements indicating how a mother felt during the previous week. Each response is scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. Scores range from 0-30. Scoring above 12 or 13 are likely to be suffering from depression and should seek medical attention. A careful clinical evaluation by a health care professional is needed to confirm a diagnosis and establish a treatment plan.
Measured: Baseline and 1 year postpartum (T12)
Depressive Symptoms (CESD)
Scores from the Center for Epidemiological Studies-Depression (CESD)
This scale is a self-report measure of depression. Questions measure 8 different subscales, including: Sadness (Dysphoria): (Q. 2, 4, 6), Loss of Interest (Anhedonia): (Q. 8, 10), Appetite: (Q. 1, 18), Sleep: (Q. 5, 11, 19), Thinking / concentration: (Q. 3, 20), Guilt (Worthlessness): (Q. 9, 17), Tired (Fatigue): (Q. 7, 16), Movement (Agitation): (Q. 12, 13), Suicidal Ideation: (Q. 14, 15) Each response is scored 0, 1, 2 and 3 based on the frequency of the symptom. The total score is calculated by finding the sum of 20 items. Scores range from 0-60. A score equal to or above 16 indicates a person at risk for clinical depression.
Measured: Baseline and 1 year postpartum (T12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Feb 2017
- Primary completion25 Jan 2024
- Study completion21 Jun 2024
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The intervention model is a nonrestricted sequential multiple assignment randomized trial (SMART). Participants are randomized to intervention or control during pregnant and again postpartum.
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michele Levine, University of Pittsburgh
- Investigators
- Michele Levine, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069690
- Sponsor's protocol ID
- PRO16020497
- Other IDs
- R01HL132578-01
- Acronym
- HABIT
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2017
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jouppi RJ, Donofry SD, Call CC, Conlon RPK, Brown LB, Hawkins MS, Levine MD. Prenatal loss of control eating and cardiovascular health: Extending prior findings. Health Psychol. 2026 Sep 21. doi: 10.1037/hea0001644. Online ahead of print.
PubMed 42765991Donofry SD, Damon ST, Jouppi RJ, Davis JA, Kolko Conlon RP, Call CC, Levine MD. Depressive symptoms mediate the relationship between dispositional mindfulness and dietary quality on weekends but not weekdays among pregnant individuals with pre-pregnancy BMI>/=25. Appetite. 2026 Jul 1;222:108545. doi: 10.1016/j.appet.2026.108545. Epub 2026 Mar 18.
PubMed 41861918Jouppi RJ, Vize CE, Call CC, Emery Tavernier RL, Brown LB, Kolko Conlon RP, Grace JL, Sweeney GM, Levine MD. Pregnancy Eating Attitudes-Questionnaire (PEA-Q): Longitudinal measurement invariance from early to late pregnancy in a community sample. Appetite. 2026 Apr 1;219:108421. doi: 10.1016/j.appet.2025.108421. Epub 2025 Dec 11.
PubMed 41390087
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Health From Pregnancy Through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial (SMART) of Perinatal Lifestyle Interventions
- ClinicalTrials.gov ID
- NCT03069690
- Acronym / sponsor ID
- HABIT / PRO16020497
- Conditions
- Obesity, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact of different combinations of intervention as a function of gestational weight gain in pregnant woman. Participants will be randomized at two points during the study. Participants will first be randomized at enrollment to receive study intervention during pregnancy or treatment as usual. Participants will also be randomized just before delivery to receive intervention postpartum or treatment as usual.
Detailed description
The perinatal period, from pregnancy through the first postpartum year, has important implications for women's health. Excessive gestational weight gain is linked to deleterious health outcomes; yet most women exceed guidelines established for gestational weight gain , particularly women who begin pregnancy overweight or obese. These women are likely to remain overweight or obese at one year postpartum even if gestational weight gain is within guidelines and pregnancy-related weight gain is lost postpartum. Efforts to mitigate the health risks related to perinatal overweight can have substantial benefits for women's longer-term obesity and cardiometabolic health. To date, interventions to minimize excessive gestational weight gain alone have had limited impact. Some women may require continued intervention in the postpartum period to achieve optimal weight management. Alternatively, intervention delivered only postpartum may be sufficient to achieve a healthier weight at one year postpartum. It also is important to adapt intervention as women's needs vary over the course of pregnancy and postpartum. Accordingly, this application proposes a sequential multiple assignment randomized trial (SMART) to determine the efficacy of different intervention sequences during pregnancy, postpartum, or both. This non-restricted SMART also will allow investigators to investigate the impact of different combinations of intervention as a function of gestational weight gain. The proposed SMART is innovative as the first effort to evaluate different sequences of intervention across the perinatal period to mitigate maternal health risk by one year postpartum.
Pregnant women (N=300), stratified by prenatal weight status (body mass index=25-29.9 vs. ≥30) will be enrolled at entry into prenatal care and randomized initially to intervention that addresses the challenges of weight and self-regulation during pregnancy, Health and Behaviors in Transition (HABITpreg), or an educationally-enhanced treatment as usual (TAUpreg). At delivery, women will be re-randomized to a postpartum self-regulation intervention (HABITpost) or educationally-enhanced treatment as usual (TAUpost). Women will complete assessments at a prenatal baseline, the end of pregnancy, and 6- and 12-months postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The intervention model is a nonrestricted sequential multiple assignment randomized trial (SMART). Participants are randomized to intervention or control during pregnant and again postpartum.
| Arm | Type | Receives |
|---|---|---|
| HABITpreg; TAUpost | Experimental | Behavioral: HABITpregParticipants will receive study intervention during pregnant and treatment as usual postpartum. |
| HABITpreg, HABITpost | Experimental | Behavioral: HABITpreg, Behavioral: HABITpostParticipants will receive study intervention during pregnancy and study intervention during the postpartum period. |
| TAUpreg; HABITpost | Experimental | Behavioral: HABITpostParticipants will receive treatment as usual during pregnancy and study intervention during the postpartum period. |
| TAUpreg; TAUpost | No intervention | –Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have a prenatal BMI ≥ 25
- Are at or before 18 weeks and 4 days of gestation
- Are English speaking
- Have a singleton pregnancy
Key exclusion criteria (5 listed)
- Multiple gestations
- Preexisting diabetes
- Previous bariatric surgery in the previous 3 years
- Use of medications known to affect weight (e.g., second generation antipsychotic medications, regular steroid use).
- Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
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 |
|---|---|---|
| HABITpregTreatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included. Due to COVID-19(coronavirus disease) restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. | Behavioural | HABITpreg, HABITpost, HABITpreg; TAUpost |
| HABITpostTreatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues. Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020. | Behavioural | HABITpreg, HABITpost, TAUpreg; HABITpost |
Primary outcome
Maternal Weight
Time frame: Baseline and 1 year postpartum
Maternal weight in lbs
4 secondary outcomes
Maternal Lipids
Time frame: Baseline and 1 year postpartum (T12)
Maternal Inflammatory Markers
Time frame: Baseline and 1 year postpartum (T12)
Depressive Symptoms (EPDS)
Time frame: Baseline and 1 year postpartum (T12)
Depressive Symptoms (CESD)
Time frame: Baseline and 1 year postpartum (T12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42765991Jouppi RJ, Donofry SD, Call CC, Conlon RPK, Brown LB, Hawkins MS, Levine MD. Prenatal loss of control eating and cardiovascular health: Extending prior findings. Health Psychol. 2026 Sep 21. doi: 10.1037/hea0001644. Online ahead of print.
- Derived from this study: PubMed 41861918Donofry SD, Damon ST, Jouppi RJ, Davis JA, Kolko Conlon RP, Call CC, Levine MD. Depressive symptoms mediate the relationship between dispositional mindfulness and dietary quality on weekends but not weekdays among pregnant individuals with pre-pregnancy BMI>/=25. Appetite. 2026 Jul 1;222:108545. doi: 10.1016/j.appet.2026.108545. Epub 2026 Mar 18.
- Derived from this study: PubMed 41390087Jouppi RJ, Vize CE, Call CC, Emery Tavernier RL, Brown LB, Kolko Conlon RP, Grace JL, Sweeney GM, Levine MD. Pregnancy Eating Attitudes-Questionnaire (PEA-Q): Longitudinal measurement invariance from early to late pregnancy in a community sample. Appetite. 2026 Apr 1;219:108421. doi: 10.1016/j.appet.2025.108421. Epub 2025 Dec 11.
- 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.
Michele Levine, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABITpreg and HABITpost in people with Obesity and Pregnancy Related, run by University of Pittsburgh 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 4 inclusion and 5 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 16 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2025). 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?
Maternal Weight (time frame: Baseline and 1 year postpartum). 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 NCT03069690, 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 16 Apr 2025.