Clinical trial NCT03321071: Healthy Summer Learners
Official title: Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight and Obesity
Academic Acheivement
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Summer vacation represents a "window of vulnerability" where dramatic declines in both health and academics occur for elementary age children. Currently, there are no summer programs that incorporate curriculum addressing both unhealthy weight gains and academic achievement simultaneously. This work represents an important step towards addressing important public health goals - obesity and learning - through a comprehensive program delivered during a timeframe - summer vacation - where substantial and long-lasting negative effects occur.

Detailed description: Summer vacation represents an important time away from the school setting for a majority of children attending public school in the US. This break is characterized by large amounts of free time and involvement in a wide variety of formal and informal activities, time spent with friends and family, and travel. Yet for many children, particularly those from low-income households, summer vacation represents a "window of vulnerability" in which dramatic declines in both health and academics occur. During the summer months (typically 3 months) children gain a larger amount of body weight compared to the amount of weight gained over the school year, and weight gain during summer reverses weight losses achieved during school. For academics, it is well established that children from low-income households experience greater declines in reading and math during the summer than their middle-to-upper income peers. Numerous programs that address these issues currently exist (e.g., summer school, summer weight loss or fitness programs). However, these programs are designed and delivered at the expense of the promotion or prevention of the other - academic focus without health or health focus without academics. Our long-term goal is to develop summer programming for widespread dissemination that addresses both lifestyle behaviors (i.e., physical activity and nutrition) and academic performance. The objective of the proposed study is to establish the effectiveness of an innovative "Healthy Summer Learners" (HSL) program for low-income, minority children. The rationale for the proposed research is that no summer programs incorporate curriculum that addresses both unhealthy weight gains and academic achievement simultaneously. This study seeks to fill this void by testing a prototype learning and health-oriented summer program focused on promoting physical activity and nutrition, along with content that provides quality learning experiences to develop reading and math skills. To accomplish this objective, this study will evaluate over 2 summers the effectiveness of a 6-week Healthy Summer Learners program delivered within a Boys \& Girls Club summer camp using a randomized design in a sample of rising 2nd, 3rd, and 4th graders. The aims of the study are Aim 1: Evaluate the impact of Healthy Summer Learners on children's weight gain and academic performance from beginning (end of Spring school year) to the end of summer (beginning of Fall school year), and Aim 2: Evaluate the feasibility and acceptability of Healthy Summer Learners to children, parents, and program staff.

Eligibility criteria: Inclusion Criteria:

* MAP scores are norm referenced based on typical grade level scores. Students that have scored between the 25th and 75th percentile will be eligible to participate in the study.

Exclusion Criteria:

* children with severe intellectual or physical disabilities

Primary outcomes:
measure: Change in Body Mass Index (BMI) Z-score
timeFrame: Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
measure: Change in Measures of Academic Progress Reading Scores
timeFrame: MAP reading scores will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
Secondary outcomes:
measure: Average Minutes Per Day Spent in Moderate to Vigorous Physical Activity During the Summer on Days Attending a Program and Not Attending a Program
timeFrame: Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
measure: Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program
timeFrame: Sedentary time will be collected daily from baseline to 12 weeks
measure: Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program
timeFrame: Screen time will be collected twice weekly from baseline to 12 weeks
measure: Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program
timeFrame: Diet will be collected twice weekly from baseline to 12 weeks
measure: Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program
timeFrame: Sleep will be collected daily from baseline to 12 weeks
measure: Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program.
timeFrame: Sleep onset will be collected daily from baseline to 12 weeks
measure: Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program
timeFrame: Sleep offset will be collected daily from baseline to 12 weeks
measure: Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program
timeFrame: Sleep midpoint will be collected daily from baseline to 12 weeks
Other outcomes:
measure: Change in Progressive Aerobic Cardiovascular Endurance Run Laps
timeFrame: Change in Progressive Aerobic Cardiovascular Endurance Run Laps will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
citation: von Klinggraeff L, Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. Healthy Summer Learners: An explanatory mixed methods study and process evaluation. Eval Program Plann. 2022 Jun;92:102070. doi: 10.1016/j.evalprogplan.2022.102070. Epub 2022 Mar 17.
citation: Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. The impact of summer programming on the obesogenic behaviors of children: behavioral outcomes from a quasi-experimental pilot trial. Pilot Feasibility Stud. 2020 May 28;6:78. doi: 10.1186/s40814-020-00617-x. eCollection 2020.