Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment.

This study is not yet open for participant recruitment.
Verified November 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01989065
First received: November 14, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Pediatric Obesity
Behavioral: Lifestyle counseling
Behavioral: Text Messaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment Through Provider-to-parent Text Messaging.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Family Nutrition and Physical Activity Survey Score [ Time Frame: 1 month post-enrollment ] [ Designated as safety issue: No ]
    Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert.


Secondary Outcome Measures:
  • General Self-Efficacy Survey Score [ Time Frame: 1 month post-enrollment ] [ Designated as safety issue: No ]
    Validated survey measures parental general self-efficacy. 10 questions on a 5-point Likert.


Other Outcome Measures:
  • Change in child's Body Mass Index [ Time Frame: Baseline and 1-month ] [ Designated as safety issue: No ]
    Weight divided by the height squared. Gives indication of whether healthy lifestyle changes lead to short-term weight reduction.


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling
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
see arm description
Experimental: Lifestyle counseling PLUS text messaging
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 counseling
see arm description
Behavioral: Text Messaging
See Arm Description

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01989065

Contacts
Contact: Sarah C Armstrong, MD 919-620-5315 sarah.c.armstrong@duke.edu

Locations
United States, North Carolina
Duke Children's Health Center Not yet recruiting
Durham, North Carolina, United States, 27704
Contact: Sarah C Armstrong, MD    919-620-5315    sarah.c.armstrong@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Sarah C Armstrong, MD Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01989065     History of Changes
Other Study ID Numbers: Pro00050555_RDS
Study First Received: November 14, 2013
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Child obesity
childhood obesity
obesity treatment
text messaging
Lifestyle

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014