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Optimizing Health From Pregnancy Through One Year Postpartum (HABIT)

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ClinicalTrials.gov Identifier: NCT03069690
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michele Levine, University of Pittsburgh

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Pregnancy Related Behavioral: HABITpreg Behavioral: HABITpost Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Optimizing Health From Pregnancy Through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial (SMART) of Perinatal Lifestyle Interventions
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: HABITpreg; TAUpost
Participants will receive study intervention during pregnant and treatment as usual postpartum.
Behavioral: HABITpreg

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 restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020.


Experimental: HABITpreg, HABITpost
Participants will receive study intervention during pregnancy and study intervention during the postpartum period.
Behavioral: HABITpreg

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 restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020.


Behavioral: HABITpost

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.


Experimental: TAUpreg; HABITpost
Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period.
Behavioral: HABITpost

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.


No Intervention: TAUpreg; TAUpost
Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.



Primary Outcome Measures :
  1. Maternal weight [ Time Frame: 1 year postpartum ]
    weight in lbs


Secondary Outcome Measures :
  1. Maternal lipids [ Time Frame: 1 year postpartum ]
    blood analysis

  2. Maternal inflammatory markers [ Time Frame: 1 year postpartum ]
    blood analysis

  3. Depressive symptoms [ Time Frame: 1 year postpartum ]
    Scores from the Edinburgh Postnatal Depression Scale

  4. Depressive symptoms [ Time Frame: 1 year postpartum ]
    Scores from the Center for Epidemiological Studies-Depression


Other Outcome Measures:
  1. Gestational weight gain [ Time Frame: Time of delivery ]
    weight in lbs



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a prenatal BMI ≥ 25
  • Are at or before 18 weeks and 4 days of gestation
  • Are English speaking
  • Have a singleton pregnancy

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069690


Contacts
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Contact: Gina Sweeny 412-647-7183 dianagm@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Gina Sweeny    412-647-7183    dianagm@upmc.edu   
Principal Investigator: Michele Levine, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Michele Levine, PhD University of Pittsburgh
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Responsible Party: Michele Levine, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03069690    
Other Study ID Numbers: PRO16020497
R01HL132578-01 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No