Optimizing Health From Pregnancy Through One Year Postpartum (HABIT)

• ClinicalTrials.gov Identifier: NCT03069690
• Recruitment Status: Active, not recruiting
• First Posted: March 3, 2017
• Last Update Posted: February 3, 2023
• Sponsor: University of Pittsburgh
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Michele Levine, University of Pittsburgh

Study Description

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.

Study Design

• 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

Arms and Interventions

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(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.
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(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.; 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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Michele Levine, PhD; University of Pittsburgh

More Information

• 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
• Last Update Posted: February 3, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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