search
Back to results

Mood and Excess Weight Gain in Adolescent Pregnancy

Primary Purpose

Obesity, Adolescent Development, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Treatment-as-usual
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

3 Months - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 13-19 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment-as-usual

Interpersonal Psychotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility of recruitment
Rate of recruitment
Acceptability
Program session attendance measured as percentage of total sessions (6) attended
Acceptability of program
Program acceptability ratings

Secondary Outcome Measures

Depressive symptoms
Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale
Perceived stress
Perceived stress measured on the Perceived Stress Scale
Excess gestational weight gain
Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery
Maternal postpartum insulin sensitivity
Maternal postpartum insulin sensitivity
Maternal postpartum adiposity
Maternal postpartum body fat percentage
Infant adiposity
Infant body fat percentage

Full Information

First Posted
March 9, 2017
Last Updated
February 3, 2021
Sponsor
Colorado State University
Collaborators
University of Colorado, Denver, Children's Hospital Colorado
search

1. Study Identification

Unique Protocol Identification Number
NCT03086161
Brief Title
Mood and Excess Weight Gain in Adolescent Pregnancy
Official Title
Mood and Excess Weight Gain in Adolescent Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
University of Colorado, Denver, Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Obesity and its negative health consequences such as type 2 diabetes and heart disease are major public health concerns. Pregnancy is an ideal opportunity to intervene with young women both to reduce their own likelihood of long-term obesity and to potentially lessen their offspring's obesity risk. Interventions to reduce excessive weight gain during adolescent pregnancy may be particularly important. 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. Depression and stress-which are common in adolescent pregnancy-also may play a role. Pregnant adolescent females, as well as non-pregnant females, who have more frequent feelings of depression or stress are more likely to gain weight too rapidly or to gain too much weight as they grow. In the current project, the investigators seek to develop a program to prevent excess weight gain that will be feasible to administer in the Colorado Adolescent Maternity Program (CAMP) at Children's Hospital Colorado, University of Colorado Denver, Anschutz Medical Campus, and, that will be acceptable to pregnant teens at-risk for gaining too much weight. After a screening assessment, adolescent females (13-19y) will be randomly assigned to participate in either a 6-session interpersonal psychotherapy (IPT) program + usual care or to CAMP usual care only. The IPT program will involve 6 1-hour meetings with a trained facilitator and focus on improving relationships, mood, stress, and eating in response to negative feelings. The investigators will assess participants midway through the program, immediately after the program, and again at a 3-month postpartum follow-up. The investigators will evaluate to what extent adolescent females attend the program, complete at-home practice assignments, and show changes in mood, stress, relationships, eating, and mindfulness before and after IPT participation compared to usual care only. The investigators also will estimate how program participation relates to weight gain during pregnancy and 3-month postpartum maternal weight retention, adiposity, and insulin sensitivity. The investigators also will study the adiposity of adolescents' 3-month-old infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent Development, Pregnancy Related, Insulin Sensitivity, Interpersonal Relations, Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Care providers delivering usual prenatal care are unaware of condition assignment.
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment-as-usual
Arm Type
Active Comparator
Arm Description
Treatment-as-usual alone provided in the context of a multi-disciplinary teen pregnancy clinic providing wrap-around medical, nutrition, and social work care.
Arm Title
Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
Treatment-as-usual plus a six-session interpersonal psychotherapy program delivered as individual sessions by a trained facilitator every 2-3 weeks throughout pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Rate of recruitment
Time Frame
5-year period
Title
Acceptability
Description
Program session attendance measured as percentage of total sessions (6) attended
Time Frame
6-9 months
Title
Acceptability of program
Description
Program acceptability ratings
Time Frame
6-9 months
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale
Time Frame
12 months (9 months of pregnancy plus 3 months postpartum)
Title
Perceived stress
Description
Perceived stress measured on the Perceived Stress Scale
Time Frame
12 months (9 months of pregnancy plus 3 months postpartum)
Title
Excess gestational weight gain
Description
Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery
Time Frame
9 months
Title
Maternal postpartum insulin sensitivity
Description
Maternal postpartum insulin sensitivity
Time Frame
12 months (9 months of pregnancy plus 3 months postpartum)
Title
Maternal postpartum adiposity
Description
Maternal postpartum body fat percentage
Time Frame
12 months (9 months of pregnancy plus 3 months postpartum)
Title
Infant adiposity
Description
Infant body fat percentage
Time Frame
Infants: 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 13-19 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren B Shomaker, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32206334
Citation
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.
Results Reference
derived

Learn more about this trial

Mood and Excess Weight Gain in Adolescent Pregnancy

We'll reach out to this number within 24 hrs