Obesity Clinical Trial
Official title:
PAWS CLUB: Peer Education About Weight Steadiness
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).
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |