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Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents: HEALTHY SMILES (HS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Melbourne Hovell, San Diego State University
ClinicalTrials.gov Identifier:
NCT01510483
First received: November 14, 2011
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care. Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.


Condition Intervention
Obesity
Behavioral: Obesity Prevention
Behavioral: Tobacco Prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Change in Body Mass Index [ Time Frame: Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months ] [ Designated as safety issue: No ]
    Body Mass Index assessed at Baseline, 12 month, 18 months and 24 months; and every 6-8 weeks during intervention period.


Secondary Outcome Measures:
  • Change in physical and sedentary activity [ Time Frame: Baseline, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Change in dietary intake [ Time Frame: Baseline, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Change in tobacco use and exposure [ Time Frame: Baseline, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 693
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obesity prevention
Orthodontist promotion of physical activity and healthy diet
Behavioral: Obesity Prevention
Those in the experimental, obesity prevention, condition will be exposed to the office-wide intervention for diet and activity. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.
Active Comparator: Tobacco prevention
Orthodontist promotion of tobacco and second hand smoke avoidance
Behavioral: Tobacco Prevention
Those in the control, tobacco prevention, condition will be exposed to the office-wide intervention for avoidance of tobacco and second hand smoke. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.

Detailed Description:

This study will test a 18-month multi-component intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets among preteens who obtain orthodontic care. The intervention is based on the Behavioral Ecological Model (BEM), where interacting physiological, environmental, and cultural contingencies select behavior. This study will require five years to recruit 40 orthodontist offices, and 1700 youth, and implement an office-wide intervention for promoting healthy diet and physical activity among 8-14 yr old youth. Our primary aims are to detect a differential change in diet, physical activity and BMI in our experimental group compared to the tobacco prevention control group; to observe differential effects of the intervention between low vs. high SES; and similarly for males vs. females; to validate our primary outcome variables by contrasting them with a "gold standard"; and determine the degree to which family and peer encouragement for sedentary and high caloric diet at baseline increases the relative effect of the orthodontist intervention. Offices will be assigned at random to condition producing a 2 (experimental group) by 2 strata (low vs. high SES) by 2 strata (male vs. female) by 4 (repeated measures) experimental design. Those in the experimental condition will be exposed to the office-wide intervention for diet and activity; those in the control condition will be exposed to an office-wide intervention for tobacco prevention. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents. Measures of diet, physical activity, body composition, tobacco use, fitness and family and peer encouragement will occur at baseline, 12, 18, and 24 months. Differential change over time will be analyzed using Random Effects Multivariate modeling. Analyses will include control for office cluster effects and multivariate models will include analyses of hypothetical main effects, experimental group by time interactions, and moderating effects by inclusion of interaction terms for susceptibility by experimental condition and other possible moderators. Relevance: If successful, this study may inform policies that would promote all specialists (physicians, general dentists) to deliver brief counseling for diet and physical activity. Doing so might yield the cumulative exposure necessary to effect and sustain change in a large proportion of the preteen population.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 8-14 years old
  • receiving orthodontic care at a participating orthodontic office
  • at least 1 year left in braces

Exclusion Criteria:

  • participating in 9 or more months of structured
  • organized sports for 3 or more days a week, youth who have serious conditions that preclude physical activity or make the child incapable of managing his/her own care will not qualify for this study
  • individuals who report anorexia, bulimia or severe, diagnosed depression will not be eligible
  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: NCT01510483

Locations
United States, California
SDSU-Center for Behavioral Epidemiology & Community Health
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Melbourne F Hovell, PhD, MPH SDSU/GSPH
  More Information

Publications:

Responsible Party: Melbourne Hovell, Director of CBEACH, Distinguished Professor of Public Health, San Diego State University
ClinicalTrials.gov Identifier: NCT01510483     History of Changes
Other Study ID Numbers: 5R01CA138192
Study First Received: November 14, 2011
Last Updated: November 19, 2014
Health Authority: United States: Federal Government

Keywords provided by San Diego State University:
obesity prevention
tobacco prevention
nutrition
physical activity
sedentary activity
tobacco use
tobacco exposure
prevention
clinician intervention
preteen
adolescents

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

ClinicalTrials.gov processed this record on November 27, 2014