Clinical trial NCT02365324: Peer Education About Weight Steadiness
Official title: PAWS CLUB: Peer Education About Weight Steadiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Physical Activity
Keywords: culinary skills
menu planning
grocery shopping
children
healthy eating
physical activity
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2015-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed integrated project will evaluate the effects of an evidence-based extension education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of delivery on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns \[i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010\] and SCT variables. Briefly, the 12-week program will target early adolescent children, ages 11-14 years, test a peer-education approach to behavioral change and will be delivered as an after-school program in local middle schools in support of childhood obesity prevention. Data will be collected at baseline (preintervention), after the 12-week program (post-intervention) and 6 months after completion of the program (maintenance).

Detailed description: The 12-week intervention, either Family Fitness Program, FFP (adult-led control group) or Peer-education Family Fitness Program, PE-FFP (peer-led experimental group) will be delivered four times in each of the three schools participating in the study from May, 2015 to May 2017 as an after-school program to early adolescent children, ages 11-14 years, to partially meet the stated objectives in research. The proposed integrated project will follow a group-randomized controlled trial design. The intervention will be offered as an after-school programs in each of 3 schools (Urbana Middle School, Franklin Middle School and Mahomet Seymour-Junior High School). Programs will be conducted on Mondays, Tuesdays, Wednesday, and Thursdays for 12 weeks. After children are enrolled in the program, weekday by school will be randomly assigned to the adult-led FFP (control group) or to the peer-led PE-FFP (experimental group). This process will allow children the convenience of participating in the program on the day that is most compatible with their schedules, offer the control and experimental conditions at each of 2 schools and maintain randomization to treatment. Thus, each school will have 1 control group and 1 experimental group each time the program is conducted. Group randomization will occur during the fall-winter 2016 term and spring-summer 2017 term again. Data will be collected at baseline (pre-intervention), after the 12-week FFP or PE-FFP (post-intervention) and 6 months after completion of the program (maintenance). The FFP addresses all major elements of the Dietary guidelines for Americans (DGAs), 2010. Each weekly lesson will include: 1) 20-30 minutes of moderate physical activity; 2) nutrition activities; 3) discussions; 4) self-reflections; 5) goal setting activities for healthier eating and physical activity; 6) food and beverage tasting experiences; and 7) parent-child reflections. Lesson details are provided below. Incentive items will be distributed throughout the 12-week intervention. Adult educators will lead FFP lessons, while peer-educators will lead PE-FFP lessons. Study personnel will be present at each lesson, along with Illinois-Trans-disciplinary Obesity Prevention Program (I-TOPP) trainees to monitor each session and to conduct extension measures.

Lesson details:

1. Introduction to Fitness; For children: Introductions; ice-breakers; health and wellness; family physical activities and foods Energy balance; physical activity environment; body image; vegetables and fruits; family fitness For parents: An Introduction to family Fitness
2. Culinary Skills; For children: Knife safety; knife selection; cooking methods and utensils; focus on vegetables and fruits
3. Culinary Skills in Action; For children: Slicing, measuring, tasting vegetables and fruits; vegetable and fruit dishes
4. Physical Activity: Using Dietary Guidelines for Healthy Food Choices; For children and parents: Balancing calories to manage weight; energy; growth and development; growth charts; family physical activity values; building healthy eating patterns; nutrient-dense foods; flexible food patterns; vegetables and fruits; whole grains; seafood; family food choices; family food values
5. Breakfast for All; For children and parents: Increasing specific foods and nutrients; whole grains; vegetables and fruits; nutrients of concern (dietary fiber and potassium); flexible food patterns; family eating patterns; finding family time for healthy food choices and physical activities
6. Healthy Snacking and Healthy Food Choices; For children: Reducing certain foods and food components; energy-dense foods; solid fats and added sugars; sodium; refined grains; label reading (Nutrition Facts label); goal setting for food and snack choices; family snack choices For parents: Identifying and Overcoming Resistance to Change
7. Eating Out and Fast Foods; For children: Reducing certain foods and food components; label reading; menu reading; finding fats and oils; portion sizes; food advertising; food environment; eating at home with family or eating out choices
8. Healthy Beverages; For children: Increasing specific foods and nutrients; non-fat milk and dairy; water; nutrients of concern (calcium and vitamin D); food and health connections; practicing culinary skills
9. Setting Limits on Sweets and Fats; For children: Reducing certain foods and food components; finding fats and sugars in foods; practicing culinary skills; goal setting for food choices
10. Maintaining Physical Activity and Healthy Eating Patterns; For children: Balancing calories to maintain weight; Building healthy eating patterns; flexible approaches to eating; variety, balance and moderation; label reading; vegetables and fruits; whole grains; non-fat milk and dairy; seafood; oils; physical activities for the family
11. Family Menu Planning; Family food preferences and health needs; food costs and budgeting; family menus; shopping lists; family food purchasing
12. Grocery Shopping; For children: Field trip; in-store choices and selections; food costing; Wrap-Up

Eligibility criteria: Inclusion Criteria:

* Children in grade 6 or grade 7, 11-14 years old and their parents, enrolled in the schools participating in the study

Exclusion Criteria:

* Children younger than 11 years or older than 14 years, not enrolled in the schools participating in the study

Primary outcomes:
measure: Change in Demographic data
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Goal setting tool
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in 24-hour dietary intake recall
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in 3-day dietary intake record
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in 24-hour physical activity recall
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in 3-day physical activity record
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in Anthropometric measurements
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in Social Cognitive Theory (SCT) variables
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
measure: Changes in blood pressure (BP) measurements
timeFrame: Evaluation at three time points: 0 months, 2 months and 8 months
Secondary outcomes:
measure: Process measure questionnaire
timeFrame: One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)
measure: Education measures
timeFrame: Once, at the end of the 12 week intervention
measure: Extension measures
timeFrame: Once, at the end of the 12 week intervention
Other outcomes:
Locations:
city: Champaign
country: United States
facility: Franklin Middle School
state: Illinois
city: Champaign
country: United States
facility: Jefferson Middle School
state: Illinois
city: Mahomet
country: United States
facility: Mahomet Seymour-Junior High School
state: Illinois
city: Urbana
country: United States
facility: Urbana Middle School
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sharon Nickols-Richardson, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muzaffar H, Nikolaus CJ, Ogolsky BG, Lane A, Liguori C, Nickols-Richardson SM. Promoting Cooking, Nutrition, and Physical Activity in Afterschool Settings. Am J Health Behav. 2019 Nov 1;43(6):1050-1063. doi: 10.5993/AJHB.43.6.4.