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Completed

NCT Number: NCT01510483

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

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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SDSU-Center for Behavioral Epidemiology & Community Health

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obesity Prevention

Behavioral

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.

Tobacco Prevention

Behavioral

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.

Primary outcomes

  1. Change in Body Mass Index

    Time frame: Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months

    Body Mass Index assessed at Baseline, 12 month, 18 months and 24 months; and every 6-8 weeks during intervention period.

Secondary outcomes

  1. Change in physical and sedentary activity

    Time frame: Baseline, 12, 18 and 24 months

  2. Change in dietary intake

    Time frame: Baseline, 12, 18 and 24 months

  3. Change in tobacco use and exposure

    Time frame: Baseline, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents

Acronym: HS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2012
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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