Optimizing Health From Pregnancy Through One Year Postpartum

NCT03069690 | Completed Results

• 2 other identifiers: PRO16020497R01HL132578-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Maternal Weight

  Maternal weight in lbs

  Baseline and 1 year postpartum

Secondary Outcomes (4)

• Maternal Lipids

  Baseline and 1 year postpartum (T12)

• Maternal Inflammatory Markers

  Baseline and 1 year postpartum (T12)

• Depressive Symptoms (EPDS)

  Baseline and 1 year postpartum (T12)

• Depressive Symptoms (CESD)

  Baseline and 1 year postpartum (T12)

Other Outcomes (1)

• Gestational Weight Gain

  Time of delivery

Study Arms (4)

HABITpreg; TAUpost

EXPERIMENTAL

Participants will receive study intervention during pregnant and treatment as usual postpartum.

Behavioral: HABITpreg

HABITpreg, HABITpost

EXPERIMENTAL

Participants will receive study intervention during pregnancy and study intervention during the postpartum period.

Behavioral: HABITpreg; Behavioral: HABITpost

TAUpreg; HABITpost

EXPERIMENTAL

Participants will receive treatment as usual during pregnancy and study intervention during the postpartum period.

Behavioral: HABITpost

TAUpreg; TAUpost

NO INTERVENTION

Participates will receive treatment as usual during pregnancy and treatment as usual during the postpartum period.

Interventions

HABITpreg BEHAVIORAL

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.

HABITpreg, HABITpost; HABITpreg; TAUpost

HABITpost BEHAVIORAL

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.

HABITpreg, HABITpost; TAUpreg; HABITpost

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michele Levine
• Organization: University of Pittsburgh Medical Center

levinem@upmc.edu

(412) 647-0703

Study Officials

• Michele Levine, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The intervention model is a nonrestricted sequential multiple assignment randomized trial (SMART). Participants are randomized to intervention or control during pregnant and again postpartum.

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 3, 2017
• Study Start: February 1, 2017
• Primary Completion: January 25, 2024
• Study Completion: June 21, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)