Mood and Excess Weight Gain in Adolescent Pregnancy

NCT03086161 | Completed

• 1 other identifier: 14-1505
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.

Conditions

Obesity; Adolescent Development; Pregnancy Related; Insulin Sensitivity; Interpersonal Relations; Stress

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruitment

  Rate of recruitment

  5-year period

• Acceptability

  Program session attendance measured as percentage of total sessions (6) attended

  6-9 months

• Acceptability of program

  Program acceptability ratings

  6-9 months

Secondary Outcomes (6)

• Depressive symptoms

  12 months (9 months of pregnancy plus 3 months postpartum)

• Perceived stress

  12 months (9 months of pregnancy plus 3 months postpartum)

• Excess gestational weight gain

  9 months

• Maternal postpartum insulin sensitivity

  12 months (9 months of pregnancy plus 3 months postpartum)

• Maternal postpartum adiposity

  12 months (9 months of pregnancy plus 3 months postpartum)

Study Arms (2)

Treatment-as-usual

ACTIVE COMPARATOR

Treatment-as-usual alone provided in the context of a multi-disciplinary teen pregnancy clinic providing wrap-around medical, nutrition, and social work care.

Behavioral: Treatment-as-usual

Interpersonal Psychotherapy

EXPERIMENTAL

Treatment-as-usual plus a six-session interpersonal psychotherapy program delivered as individual sessions by a trained facilitator every 2-3 weeks throughout pregnancy.

Behavioral: Interpersonal Psychotherapy; Behavioral: Treatment-as-usual

Interventions

Interpersonal Psychotherapy BEHAVIORAL

Six individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy

Interpersonal Psychotherapy

Treatment-as-usual BEHAVIORAL

Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work

Interpersonal Psychotherapy; Treatment-as-usual

Eligibility Criteria

• Age: 3 Months - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age and the 3-6 month old infants of these adolescent mothers
• Female
• Pregnant, 12-18 weeks gestation
• Patient in the Colorado Adolescent Maternity Program (CAMP) clinic

You may not qualify if:

• Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)
• Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder
• Medication affecting mood or body weight
• Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)
• Pre-pregnancy BMI \<5th percentile for age and sex

Sponsors & Collaborators

• Colorado State University: lead
• University of Colorado, Denver: collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Shomaker LB, Gulley LD, Clark ELM, Hilkin AM, Pivarunas B, Tanofsky-Kraff M, Nadeau KJ, Barbour LA, Scott SM, Sheeder JL. Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents. Pilot Feasibility Stud. 2020 Mar 20;6:39. doi: 10.1186/s40814-020-00578-1. eCollection 2020.

  PMID: 32206334 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lauren B Shomaker, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care providers delivering usual prenatal care are unaware of condition assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 22, 2017
• Study Start: November 23, 2015
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)