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Completed

NCT Number: NCT02365324

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).

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Middle School, Champaign, Illinois, United States

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About this study

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:

  • 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
  • Culinary Skills; For children: Knife safety; knife selection; cooking methods and utensils; focus on vegetables and fruits
  • Culinary Skills in Action; For children: Slicing, measuring, tasting vegetables and fruits; vegetable and fruit dishes
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Family Menu Planning; Family food preferences and health needs; food costs and budgeting; family menus; shopping lists; family food purchasing
  • Grocery Shopping; For children: Field trip; in-store choices and selections; food costing; Wrap-Up

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer-Education Family Fitness Program (PE-FFP)

Behavioral

The proposed integrated project will be implemented by peers and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (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.

Other names: PAWS Club: Peer-education About Weight Steadiness

Family Fitness Program (FFP)

Behavioral

The proposed integrated project will be implemented by adults and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (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.

Other names: PAWS Club: Peer-education About Weight Steadiness

Primary outcomes

  1. Change in Demographic data

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    Children will complete a standardized questionnaire to provide age, gender, race/ethnicity, grade level and home address. Information about health (any acute or chronic illnesses) and health care services utilization (frequency of doctor's visits, use of specialists, medication use or need) will be provided by parents.

  2. Goal setting tool

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    Children and parents will complete the Goal Setting for Family Fitness tool. Children and adults, respectively, will complete the Child or Adult versions of the Pre-Survey (baseline), Post-Survey (post-intervention) and Follow-Up Survey (6-months post-intervention).

  3. Changes in 24-hour dietary intake recall

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    24-hour dietary intake recall completed by the multiple-pass method in an interview format.

  4. Changes in 3-day dietary intake record

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    3-day dietary intake record (2 weekdays+1 weekend day).

  5. Changes in 24-hour physical activity recall

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    Average energy expenditure of children (kcals/day) will be estimated from 1, 24-hour physical activity recall completed in an interview format.

  6. Changes in 3-day physical activity record

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    3-day physical activity record (2 weekdays+1 weekend day).

  7. Changes in Anthropometric measurements

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    In a private room with the child's parent present, a graduate research assistant (GRA) will measure the child's BW (kg) on a calibrated scale (Seca 700, Hanover, MD) to the nearest 0.1 kg and body height (cm) to the nearest 0.1 cm with a calibrated, standing stadiometer (Seca 700).

  8. Changes in Social Cognitive Theory (SCT) variables

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    Social/family support, self-efficacy, self-regulation and outcome expectations for balancing calories to manage BW, reducing certain foods and food components, increasing selected foods and nutrients and building healthy eating patterns will be assessed by questionnaires.

  9. Changes in blood pressure (BP) measurements

    Time frame: Evaluation at three time points: 0 months, 2 months and 8 months

    Seated systolic and diastolic BP (mmHg) will be measured by a trained GRA, using a sphygmomanometer (Baumanometer® Desk Model, Copiague, NY). Two BP measurements will be recorded with a 3-minute rest period between readings; values will be averaged.

Secondary outcomes

  1. Process measure questionnaire

    Time frame: One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)

    Program staff will administer the process measure questionnaire at the end of each session (12 sessions) to record information about participant attendance (children and adults), engagement during each weekly lessons and completion of program worksheets, and evaluate adult-educator and peer-educator program fidelity for each session for all control (FFP) and experimental (PE-FFP) groups.

  2. Education measures

    Time frame: Once, at the end of the 12 week intervention

    The RE-AIM framework will be used as the foundation for measuring education and extension outcomes. Reach, efficacy, adoption, implementation and maintenance (REAIM) will be measured.

  3. Extension measures

    Time frame: Once, at the end of the 12 week intervention

    Reach, Efficacy, Adoption, Implementation and Maintenance of the program will be determined at the end of the 12-week intervention.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Penn State University

Registry information

Official study title

PAWS CLUB: Peer Education About Weight Steadiness

Acronym: PAWS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2015
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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