Optimizing Health From Pregnancy Through One Year Postpartum

Not Applicable

Completed

Conditions: Obesity
Pregnancy Related

Interventions: Behavioral: HABITpreg
Behavioral: HABITpost

Registration Number: NCT03069690

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 320

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HABITpreg; TAUpost	HABITpreg	Participants will receive study intervention during pregnant and treatment as usual postpartum.
HABITpreg, HABITpost	HABITpost	Participants will receive study intervention during pregnancy and study intervention during the postpartum period.
TAUpreg; HABITpost	HABITpost	Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period.
HABITpreg, HABITpost	HABITpreg	Participants will receive study intervention during pregnancy and study intervention during the postpartum period.

Primary Outcome Measures

Name	Time	Method
Maternal Weight	Baseline and 1 year postpartum	Maternal weight in lbs

Secondary Outcome Measures

Name	Time	Method
Maternal Lipids	Baseline and 1 year postpartum (T12)	Blood Analysis of Maternal Lipids (High-Density Lipoprotein (HDL), Low-Density Lipoprotein calculated (LDL), Cholesterol, Triglyceride).
Maternal Inflammatory Markers	Baseline and 1 year postpartum (T12)	Maternal inflammatory markers from blood analysis
Depressive Symptoms (EPDS)	Baseline and 1 year postpartum (T12)	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.
Depressive Symptoms (CESD)	Baseline and 1 year postpartum (T12)	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.