Foundations of Fitness Program Pilot
8 juillet 2019 mis à jour par: Auden McClure, Dartmouth-Hitchcock Medical Center
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer.
Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this.
Clinical-community partnerships are well-positioned to address this care gap.
This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting.
In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic.
Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase.
The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change.
A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
29
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth-Hitchcock Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
7 ans à 13 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
Exclusion Criteria:
- Physical or developmental limitation to participation as determined by referring provider
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 7-10 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
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The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
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Expérimental: 11-13 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
|
The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
Délai: 24 weeks
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Programmatic feasibility will be defined as delivery of 100% of the sessions with 80% of children attending ≥75% of sessions and 80% completing pre- and post-assessments.
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24 weeks
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Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
Délai: 24 weeks
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Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
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24 weeks
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Program Eligibility rate
Délai: 24 weeks
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Calculated using the following formula: [# screen positive / # screened for inclusion].
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24 weeks
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Program Enrollment rate
Délai: 24 weeks
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Calculated using the following formula: [# enrolled / (# screen positive & eligible)].
We will assess reasons for dropout/non-adherence.
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24 weeks
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Program Completion rate
Délai: 24 weeks
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Calculated using the following formula: (# completing all sessions / # enrolled).
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24 weeks
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Assessment Completion rate
Délai: 24 weeks
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Calculated using the following formula: (# completing all assessments / # enrolled).
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24 weeks
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Participant Satisfaction Survey
Délai: 24 weeks
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A 12 item survey at program conclusion will assess patient satisfaction with program elements (overall, class sessions, staff, assessments) using Likert scales (1-5 point scale - very dissatisfied=1 to very satisfied=5).
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24 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Mass Index Percentile
Délai: 48 weeks
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Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) and then BMI percentile (%) using Center for Disease Control 2000 standards.
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48 weeks
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Strength Assessment
Délai: 24 weeks
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Assessed through 5 exercises including: leg extension, leg curl, lap pull down, shoulder press, chest press.
Units for all are number of repetitions per minute at a fixed mass (lbs).
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24 weeks
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Health Habits Survey
Délai: 24 weeks
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The Weight & Wellness Center Health Habits Survey assesses diet, activity, media and sleep behaviors through 46 individual survey questions with variable response categories (for example, overall physical activity is assessed using a 0-5 point Likert scale with higher score related to better physical activity level: " Overall my physical activity level is": Poor=0 - Excellent=5)
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24 weeks
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Subjective Health and Quality of Life Score
Délai: 24 weeks
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The Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health 7 survey (child and parent proxy) is a 7-question survey (Score 7-35) capturing physical, mental, and social aspects of quality of life using Likert scales (1-5 point scale: poor/never=1 to excellent/always=5). Higher score indicates more positive perceptions of overall health.
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24 weeks
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Sense of Belonging in Fitness Program Score
Délai: 24 weeks
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The Anderson-Butcher and Conroy Sense of Belonging survey is a 5-item questionnaire measuring sense of belonging experienced by children participating in a Fitness Program using Likert scale (1-4 point scale: NO!=1, no=2, yes=3, and YES!=4).
Total Score Range 5-20: A higher score indicates a greater sense of belonging.
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24 weeks
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Self Esteem Score
Délai: 24 weeks
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The Rosenberg Self-Esteem survey is a 10-item questionnaire measuring self-esteem of children participating in a Fitness Program using Likert scale (0-3 point scale: Strongly disagree=0 to Strongly agree=3).
Total Score Range 0-30: Higher scores indicate greater self-esteem.
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24 weeks
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Physical Activity Score
Délai: 24 weeks
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The Patient Reported Outcomes Measurement Information Systems (PROMIS) is a short form 4-question survey (Score 4-20) assessing physical activity over the past seven days using Likert scales (1-5 point scale: No days=1, 1 day=2, 2-3 days=3, 4-5 days=4, and 6-7 days=5).
Higher score indicates higher levels of physical activity.
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24 weeks
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Cardio-capacity
Délai: 24 weeks
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Distance (m) on treadmill at 65% of max heart rate.
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24 weeks
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Heart Rate
Délai: 24 weeks
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Resting and recovery heart rate (BPM) measured before and after treadmill test.
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24 weeks
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Blood Pressure
Délai: 24 weeks
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Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
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24 weeks
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Waist Circumference
Délai: 24 weeks
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Waist circumference will be measured (cm)
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24 weeks
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Perceived Athletic Competence Score
Délai: 24 weeks
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The Harter Self-Perception Profile for Children is a short form 6-question survey (score 1-4) assessing athletic competence using a two-choice format with option then of checking "Sort of True for Me" or "Really True for Me" (A score of 1 indicates lowest and a score of 4 highest level of perceived athletic competence).
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24 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Staff program adoption
Délai: 24 weeks
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Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program.
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24 weeks
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Fidelity to planned program
Délai: 24 weeks
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We will assess percent of planned class sessions and planned outcome assessments that were administered.
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24 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Auden C McClure, MD MPH, Dartmouth-Hitchcock Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 juillet 2018
Achèvement primaire (Réel)
12 juin 2019
Achèvement de l'étude (Réel)
12 juin 2019
Dates d'inscription aux études
Première soumission
18 juillet 2018
Première soumission répondant aux critères de contrôle qualité
7 août 2018
Première publication (Réel)
9 août 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juillet 2019
Dernière vérification
1 juillet 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D18143
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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Essais cliniques sur Foundations of Fitness Program
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