NCT01989065

Brief Summary

Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy Lifestyles Program by delivering educational and supportive text messages to the parent's mobile device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

November 14, 2013

Last Update Submit

December 1, 2015

Conditions

Pediatric Obesity

Keywords

Child obesitychildhood obesityobesity treatmenttext messagingLifestyle

Outcome Measures

Primary Outcomes (1)

  • Food and Activity Frequency Survey Score

    Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert.

    3 month post-enrollment

Secondary Outcomes (1)

  • General Self-Efficacy Survey Score

    3 month post-enrollment

Other Outcomes (1)

  • Change in child's Body Mass Index

    Baseline and 3-month

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

The Duke Healthy Lifestyles program is a comprehensive childhood obesity treatment program. Standard of care is active engagement and Lifestyle Counseling of families by nutritionist, physician, mental health provider, and physical therapist. Monthly visits for 1 year are recommended.

Behavioral: Lifestyle counseling

Lifestyle counseling PLUS text messaging

EXPERIMENTAL

Patients in this arm will receive full standard of care as described for the Active Comparison group. In addition, parents will be texted daily with a motivational message that provides information and support for healthy behaviors.

Behavioral: Lifestyle counselingBehavioral: Text Messaging

Interventions

Lifestyle counselingBEHAVIORAL

see arm description

Lifestyle counselingLifestyle counseling PLUS text messaging
Text MessagingBEHAVIORAL

See Arm Description

Lifestyle counseling PLUS text messaging

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adult aged 18 or older and is the child's primary caregiver ("parent")
  • Child aged 5-12 years
  • Child with age- and gender-specific BMI ≥ 95th percentile
  • Parent has mobile phone with texting plan

You may not qualify if:

  • Inability to read and write in English
  • Parent with severe medical or mental health condition limiting ability to attend appointments
  • Plan to move out of state in next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Children's Health Center

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah C Armstrong, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)