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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01989065
First received: November 14, 2013
Last updated: July 23, 2014
Last verified: July 2014
  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: September 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Pro00050555_RDS
Study First Received: November 14, 2013
Last Updated: July 23, 2014
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
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014