Obesity Prevention Clinical Trial
Official title:
Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project
This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the intervention. This will ensure that all aspects of the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and retain participants, 2) deliver the intervention, 3) implement study and assessment procedures 4) assess the reliability of the proposed measures in this sample, 5) determine whether modifications to the intervention, procedures, and measures are needed prior to conducting a fully powered study, and 6) willingness of participants to participate in the intervention.
The current study employs a 2 group randomized control design (treatment and no-treatment control) with randomization occurring after baseline (time 0) and 3 additional evaluation periods (end of intervention (time 1), and 9 months (time 2) and 12 months post intervention (time 3)). Because the the i♥rhythm project is intended to prevent children from beginning a trajectory toward overweight/obesity in elementary school, the impact of the intervention on change in standardized BMI (BMIz) during the following summer (time 2 and 3) will be explored, identifying whether a maintenance intervention is needed. Following the intervention and final data assessment (time 1 and 3), qualitative interviews will explore the acceptability of the intervention, treatment barriers and facilitators, difficulties with study procedures, maintenance of improvements, and self-efficacy to maintain improvements. A third treatment condition controlling for the effect of attention was beyond the scope of the current feasibility study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02147496 -
Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children
|
Phase 1/Phase 2 | |
| Completed |
NCT01025557 -
Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response
|
Phase 1/Phase 2 | |
| Completed |
NCT00593749 -
Healthy Corner Store Initiative
|
N/A | |
| Completed |
NCT03850821 -
Social Mechanisms for Promoting Physical Activity in After School Programs for Underserved Middle School Youth
|
N/A | |
| Completed |
NCT02385890 -
PERFECT Project - Part 1 - Study 3
|
N/A | |
| Completed |
NCT02365363 -
PERFECT Project - Part 2 - Study 3
|
N/A | |
| Completed |
NCT01042418 -
Appetite Profile After Intake of Rye Breakfast Meal
|
N/A | |
| Completed |
NCT01196351 -
Activity at Ventilation Threshold on Appetite and Food Intake in Boys
|
N/A | |
| Completed |
NCT01206413 -
A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
|
Phase 4 | |
| Completed |
NCT01996514 -
Food Advertisements, Satiety and Food Intake in Children
|
N/A | |
| Completed |
NCT02370927 -
PERFECT Project - Part 2 - Study 2
|
N/A | |
| Completed |
NCT02366598 -
A FINEH Protein Trial - Part 1
|
N/A | |
| Completed |
NCT00988377 -
The Effect of Whey Protein on Short-Term Food Intake and Post-Meal Blood Glucose Response in Young Men
|
N/A | |
| Completed |
NCT02366572 -
PERFECT Project - Part 1 - Study 2
|
N/A | |
| Completed |
NCT02402504 -
PERFECT Project - Part 1 - Study 1
|
N/A | |
| Active, not recruiting |
NCT01117363 -
Effect of Three Weeks Consumption of Rye Porridge Breakfast
|
N/A | |
| Completed |
NCT00456911 -
Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control
|
N/A | |
| Completed |
NCT00988689 -
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake
|
N/A | |
| Completed |
NCT02458027 -
Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2
|
N/A | |
| Completed |
NCT01298154 -
Effects of Intact and Hydrolyzed Pea Protein on Food Intake, Glycemic Response and Subjective Appetite
|
Phase 1 |