Optimizing Health From Pregnancy Through One Year Postpartum

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.

Conditions

• Obesity
• Pregnancy Related

Interventions

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Michele Levine, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-01

Primary Completion

2024-01-25

Completion

2024-06-21

Countries

• United States

Study Locations