ObesityPAWSNCT02365324
Peer Education About Weight Steadiness
A study testing Peer-Education Family Fitness Program (PE-FFP) and Family Fitness Program (FFP) in people with Obesity and Physical Activity, run by University of Illinois at Urbana-Champaign at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Peer-Education Family Fitness Program (PE-FFP) and Family Fitness Program (FFP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in grade 6 or grade 7, 11-14 years old and their parents, enrolled in the schools participating in the study
Who cannot join
- Children younger than 11 years or older than 14 years, not enrolled in the schools participating in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Franklin Middle School
Champaign, Illinois, 61820
Jefferson Middle School
Champaign, Illinois, 61822
Mahomet Seymour-Junior High School
Mahomet, Illinois, 61853
Urbana Middle School
Urbana, Illinois, 61801
About this study
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).
Read the 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:
- 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
- Conditions
- Obesity, Physical Activity
- Being tested
- Peer-Education Family Fitness Program (PE-FFP), Family Fitness Program (FFP)
- Keywords
- culinary skills, menu planning, grocery shopping, children, healthy eating, physical activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Education Family Fitness Program (PE-FFP)Behavioural
Also called PAWS Club: Peer-education About Weight Steadiness
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.
Family Fitness Program (FFP)Behavioural
Also called PAWS Club: Peer-education About Weight Steadiness
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-education Family Fitness Program | Experimental | Peer educators (children in grade 8) recruited from the schools participating in the study will be trained and will then be implementing the 12 week Peer-education Family Fitness Program (PE-FFP) intervention to children in 6th and 7th grade. Receives: Behavioral: Peer-Education Family Fitness Program (PE-FFP) |
| Family Fitness Program (FFP) | Other | Adult educators recruited from the University of Illinois Extension or the community will be trained and will then be implementing the 12 week Family Fitness Program (FFP) intervention to children in 6th and 7th grade. Receives: Behavioral: Family Fitness Program (FFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Demographic data
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.
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Goal setting tool
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).
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in 24-hour dietary intake recall
24-hour dietary intake recall completed by the multiple-pass method in an interview format.
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in 3-day dietary intake record
3-day dietary intake record (2 weekdays+1 weekend day).
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in 24-hour physical activity recall
Average energy expenditure of children (kcals/day) will be estimated from 1, 24-hour physical activity recall completed in an interview format.
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in 3-day physical activity record
3-day physical activity record (2 weekdays+1 weekend day).
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in Anthropometric measurements
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).
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in Social Cognitive Theory (SCT) variables
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.
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Changes in blood pressure (BP) measurements
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.
Measured: Evaluation at three time points: 0 months, 2 months and 8 months
Secondary outcomes (3)
Process measure questionnaire
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.
Measured: One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)
Education measures
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.
Measured: Once, at the end of the 12 week intervention
Extension measures
Reach, Efficacy, Adoption, Implementation and Maintenance of the program will be determined at the end of the 12-week intervention.
Measured: Once, at the end of the 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Sponsor
- Investigators
- Sharon Nickols-Richardson, PhD, RD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365324
- Sponsor's protocol ID
- UIllinoisUC
- Other IDs
- 2012-68001-19652
- Acronym
- PAWS
- Status last verified
- Nov 2016
- First submitted
- 2 Feb 2015
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31662165
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAWS CLUB: Peer Education About Weight Steadiness
- ClinicalTrials.gov ID
- NCT02365324
- Acronym / sponsor ID
- PAWS / UIllinoisUC
- Conditions
- Obesity, Physical Activity
- Keywords
- culinary skills, menu planning, grocery shopping, children, healthy eating, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- May 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-education Family Fitness Program | Experimental | Behavioral: Peer-Education Family Fitness Program (PE-FFP)Peer educators (children in grade 8) recruited from the schools participating in the study will be trained and will then be implementing the 12 week Peer-education Family Fitness Program (PE-FFP) intervention to children in 6th and 7th grade. |
| Family Fitness Program (FFP) | Other | Behavioral: Family Fitness Program (FFP)Adult educators recruited from the University of Illinois Extension or the community will be trained and will then be implementing the 12 week Family Fitness Program (FFP) intervention to children in 6th and 7th grade. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in grade 6 or grade 7, 11-14 years old and their parents, enrolled in the schools participating in the study
Key exclusion criteria (1 listed)
- Children younger than 11 years or older than 14 years, not enrolled in the schools participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Education Family Fitness Program (PE-FFP)Also: PAWS Club: Peer-education About Weight SteadinessThe 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. | Behavioural | Peer-education Family Fitness Program |
| Family Fitness Program (FFP)Also: PAWS Club: Peer-education About Weight SteadinessThe 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. | Behavioural | Family Fitness Program (FFP) |
Primary outcome
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.
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).
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.
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).
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.
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).
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).
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.
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.
3 secondary outcomes
Process measure questionnaire
Time frame: One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)
Education measures
Time frame: Once, at the end of the 12 week intervention
Extension measures
Time frame: Once, at the end of the 12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 31662165Muzaffar 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.
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Nickols-Richardson, PhD, RD principal investigator
University of Illinois at Urbana-Champaign
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Education Family Fitness Program (PE-FFP) and Family Fitness Program (FFP) in people with Obesity and Physical Activity, run by University of Illinois at Urbana-Champaign at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Demographic data (time frame: Evaluation at three time points: 0 months, 2 months and 8 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.