ObesityEIPNCT03643341
Family Healthy Living Early Intervention Program
A study testing Family Healthy Living in people with Obesity and Health Behavior, run by University of Victoria at 10 sites in Canada.
Trial summary
The Childhood Healthy Weights Early Intervention Program (EIP) is a family-based pilot program that will promote healthy lifestyle practices for families whose children are off the healthy weight trajectory (e.g., BMI ≥ 85th percentile for age and sex) that do not need the intensive services of medically supervised… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Health Behavior, Child Behavior
- What is being tested?
- Family Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 10 sitesCanada
- Study dates
- 10 Oct 2018to 31 Mar 2019
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child with BMI ≥ 85th percentile for age and sex
- Child is accompanied by a parent or legal guardian
- At least one member of the family have to be able to speak and read English
- Family agrees to attend group meetings over 10 weeks
Who cannot join
- Child unavailable to attend group weekly sessions
- Parent or guardian unavailable to attend group weekly sessions
- Participating child or parent, according to parent report, has medical condition contraindicating mild energy restriction or moderate physical activity, and medical clearance was not obtained
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites, 10 recruiting
- Recruiting
Cameron Recreation Centre
Burnaby, British Columbia, V3J 1L6
Marisa Plasterer, marisa.plasterer@burnaby.ca
- Recruiting
Strathcona Gardens Recreation Complex
Campbell River, British Columbia, V9W8C8
Debra Wilson, DWilson@srd.ca
- Recruiting
Neighbourhood Learning Centre
Chilliwack, British Columbia, V2P2P8
Serena Bring, serena.bring@gv.ymca.ca
- Recruiting
Kelowna Family YMCA
Kelowna, British Columbia, V1X2M9
Kelley Taylor, ktaylor@ymcaokanagan.ca
- Recruiting
Cowichan Open Learning/Duncan Elementary School
North Cowichan, British Columbia, V9L2E6
Jill Amy, Jill.Amy@northcowichan.ca
- Recruiting
YMCA Northern BC
Prince George, British Columbia
Melissa Cailleaux, melissa.cailleaux@nbc.ymca.ca
- Recruiting
Tong Louie YMCA
Surrey, British Columbia, V3S7S6
Serena Bring, serena.bring@gv.ymca.ca
- Recruiting
Surrey Sport & Leisure Complex
Surrey, British Columbia, V4N0E9
Caitlin Davies, CDavies@surrey.ca
- Recruiting
Langara Family YMCA
Vancouver, British Columbia, V5Y2Z5
Serena Bring, serena.bring@gv.ymca.ca
- Recruiting
Juan de Fuca Recreation Centre
Victoria, British Columbia, V9B1J1
Nicky Brown, nbrown@westshorerecreation.ca
Geoff Welham, gwelham@westshorerecreation.ca
About this study
Official title: Family-based, Healthy Living Intervention for Children With Overweight and Obesity and Their Families
The Childhood Healthy Weights Early Intervention Program (EIP) is a family-based pilot program that will promote healthy lifestyle practices for families whose children are off the healthy weight trajectory (e.g., BMI ≥ 85th percentile for age and sex) that do not need the intensive services of medically supervised programs. It is a lifestyle behaviour approach for promoting healthy weights in children. The EIP program consists of 10 weekly intervention sessions (1.5 hours per session) followed by 4 maintenance sessions and is age specific (age 8-12). During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. The program will be integrated and aligned with existing BC-specific childhood healthy weights programs (e.g. the HealthLinkBC Eating and Activity Program for Kids). The EIP pilot will run from October-December 2018 with 8 child programs (age 8-12). Participants who do not qualify for this program (e.g., BMI ≤ 85th percentile for age and sex) will be offered a 10 week online program which is similar in educational content as the EIP program.
- Conditions
- Obesity, Health Behavior, Child Behavior, Child Obesity, Nutrition Disorders, Body Weight
- Being tested
- Family Healthy Living
- Keywords
- Family-based, Community-based, Healthy Weights
- Medical subject headings
- Obesity, Health Behavior, Child Behavior, Pediatric Obesity, Nutrition Disorders, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Healthy LivingBehavioural
Children aged 8-12 and at least one caregiver will meet for 10 weekly intervention sessions (1.5 hours per session), and 4 extra sessions to be chosen by families and intervention Leaders. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. Four biweekly maintenance sessions will follow the main program.
| Study group | Role | What they receive |
|---|---|---|
| Family Healthy Living Intervention | Experimental | Children aged 8-12 and at least one caregiver will meet for 10 weekly face-to-face and online intervention sessions (1.5 hours per session). Four biweekly maintenance sessions will follow the main program. Receives: Behavioral: Family Healthy Living |
| Wait-list control group | No intervention | Children aged 8-12 will be randomly assigned to the wait-list control group until after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BMI calculated from measures of height and weight
Measures of height and weight will be obtained from all children. BMI will be calculated as weight (kilograms) divided by height (meters) squared, adjusted for child age and sex.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Secondary outcomes (31)
Changes in BMI z-score calculated from measures of height and weight
Measures of height and weight will be obtained from all children, BMI z-scores (standard deviation) will be calculated.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C)
Self-reported child usual physical activity engagement will be assessed by PAQ-C 7-day physical activity recall
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Motivation and Confidence assessed by the Canadian Assessment of Physical Literacy (CAPL-2) Physical Activity Motivation and Confidence subscale
Child questionnaire. The Motivation and Confidence sub-scale of CAPL-2 assesses physical activity predilection and adequacy, perceived physical activity intrinsic motivation and competence
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures
Child questionnaire. The PACE Adolescent Psychosocial Measures assesses physical activity, confidence, and family support
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures
Child questionnaire. The PACE Adolescent Psychosocial Measures assesses sedentary habits, confidence, and family support
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Fundamental Movement Skills (FMS) assessed by the Canadian Agility and Movement Skill Assessment (CAMSA)
CAMSA is the FMS course from the Canadian Assessment of Physical Literacy (CAPL-2) that assesses two-foot jumping, sliding, catch, throw, skip, one-foot hop, and kick. Children will observe two demonstrations, will complete two trials, and two timed and scored trials.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Dietary Behaviours assessed by the LiGHT questionnaire (7-day recall questions retrieved from CDC BRFSS surveys)
Child questionnaire. Dietary behaviours such as fruits, vegetables, fruit juice, soda, fruit-flavored beverages, and pastries intake will be assessed by the 7-day dietary recall
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Healthy Eating Outcome Expectations assessed by the Power Play! Survey.
Child questionnaire. Knowledge or ideas about what will happen when regularly consuming fruits and vegetables.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures
Child questionnaire. Self-efficacy to increase fruit and vegetable intake, and to reduce the intake of sugary beverages and sweet/salty snack foods will be assessed.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire
Child questionnaire. Motivation for eating fruits and vegetables will be assessed. Motivation for limiting sweet/salty snack foods and sugary drinks will also be assessed.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire
Child questionnaire. Assesses child's ability to prepare and cook food
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Self-esteem assessed by the Project EAT survey
Child questionnaire. Self-esteem will be assessed by the Project EAT survey
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Gratitude assessed by the Gratitude Adjective Checklist
Child questionnaire. Changes in Gratitude assessed using the Gratitude Adjective Checklist
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Self-compassion by the Self-compassion Scale Short Form
Child questionnaire. Changes in Gratitude assessed using the Self-compassion Scale Short Form
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Sleep Habits assessed by the FLASHE questionnaire
Child questionnaire. Usual hours of sleep will be self-reported by the child
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys.
Parent questionnaire. The FLASHES-EAT survey assess how parents communicate with their children regarding food and dietary habits and how they organize and monitor the home food environment.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire
Parent questionnaire. The CANPOWER questionnaire assesses whether or not parents encourage their child to participate in healthy lifestyle behaviors (eating fruits and vegetables)
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire
Parent questionnaire. This questionnaire assess each parent's specific behavioral constructs (affective attitude, instrumental attitude) in regards to supporting their child's healthy eating behaviors.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Structure of the Home Food Environment assessed by the Fruit and Vegetable At Home Survey For Parents.
Parent questionnaire. The Fruit and Vegetable At Home Survey For Parents assess the availability and accessibility of fruits and vegetables within the home.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent's Personal Dietary Behaviours are assessed by the FLASHE questionnaire.
Parent questionnaire. The FLASHE questionnaire assess parents' fruit and vegetable intake in addition to their consumption of food away from the home (e.g. fast-food restaurants, work cafeteria).
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Food Preparation Self-efficacy assessed with two questions drawn from the FLASHES-EAT survey.
Parent questionnaire. The questions drawn from the FLASHES-EAT survey assess parents' confidence level with preparing a variety of fruits and vegetables as well as their level of confidence preparing family meals with their children.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Behavioral Regulation of Supporting Child's Healthy Eating assessed by the Action Control of Parent Support Behaviour
Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child's healthy eating behaviors.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Habits assessed by the automaticity subscale of Self-Report Index of Habit.
Parent questionnaire. The Self-Report Index of Habit assess whether or not parents believe that preparing and eating healthy meals is something their family does habitually.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
Parent questionnaire. These questions assess how parents view their own and their family's dietary behaviors and food choices.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey
Parent questionnaire. Changes in Parent Physical Activity Support will be assessed by the ParticipACTION 24hr Guidelines Survey
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
Parent questionnaire. Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Behavioral Regulation of Supporting Child's Physical Activity assessed by the Action Control of Parent Support Behaviour
Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child's physical activity participation.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Habit assessed by the automaticity subscale of the Self-Report Index of Habit
Parent questionnaire. The Self-Report Index of Habit assess whether or not parents believe that participating in physical activity is something their family does habitually.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
Parent questionnaire. These questions assess how parents view their own and their family's physical activity participation.
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Support for Child Sleep Habits assessed by the ParticipACTION 24hr Guidelines Survey
Parent questionnaire. Changes in Parent Support for Child Sleep Habits will be assessed by the ParticipACTION 24hr Guidelines Survey
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Child Quality of Life assessed by the Pediatric Quality of Life Inventory
Parent questionnaire. Changes in Child Quality of Life will be assessed by the Pediatric Quality of Life Inventory
Measured: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start10 Oct 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Collaborators
- Childhood Obesity Foundation
- Responsible party
- Principal investigator, Patti-Jean Naylor, University of Victoria
- Investigators
- Karen Strange, PhD, Study director, Childhood Obesity Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643341
- Sponsor's protocol ID
- BC18-024
- Acronym
- EIP
- Status last verified
- Oct 2018
- First submitted
- 6 Jul 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be share with co-investigators
Publications
Perdew M, Liu S, Rhodes R, Ball GDC, Masse LC, Hartrick T, Strange K, Naylor PJ. The Effectiveness of a Blended In-Person and Online Family-Based Childhood Obesity Management Program. Child Obes. 2021 Jan;17(1):58-67. doi: 10.1089/chi.2020.0236. Epub 2020 Dec 23.
PubMed 33370164Liu S, Marques IG, Perdew MA, Strange K, Hartrick T, Weismiller J, Ball GDC, Masse LC, Rhodes R, Naylor PJ. Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. BMJ Open. 2019 Oct 31;9(10):e027183. doi: 10.1136/bmjopen-2018-027183.
PubMed 31676642
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based, Healthy Living Intervention for Children With Overweight and Obesity and Their Families
- ClinicalTrials.gov ID
- NCT03643341
- Acronym / sponsor ID
- EIP / BC18-024
- Conditions
- Obesity, Health Behavior, Child Behavior, Child Obesity, Nutrition Disorders, Body Weight
- Keywords
- Family-based, Community-based, Healthy Weights
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- Childhood Obesity Foundation
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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 Childhood Healthy Weights Early Intervention Program (EIP) is a family-based pilot program that will promote healthy lifestyle practices for families whose children are off the healthy weight trajectory (e.g., BMI ≥ 85th percentile for age and sex) that do not need the intensive services of medically supervised programs. It is a lifestyle behaviour approach for promoting healthy weights in children. The EIP program consists of 10 weekly intervention sessions (1.5 hours per session) followed by 4 maintenance sessions and is age specific (age 8-12). During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. The program will be integrated and aligned with existing BC-specific childhood healthy weights programs (e.g. the HealthLinkBC Eating and Activity Program for Kids). The EIP pilot will run from October-December 2018 with 8 child programs (age 8-12). Participants who do not qualify for this program (e.g., BMI ≤ 85th percentile for age and sex) will be offered a 10 week online program which is similar in educational content as the EIP program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Healthy Living Intervention | Experimental | Behavioral: Family Healthy LivingChildren aged 8-12 and at least one caregiver will meet for 10 weekly face-to-face and online intervention sessions (1.5 hours per session). Four biweekly maintenance sessions will follow the main program. |
| Wait-list control group | No intervention | –Children aged 8-12 will be randomly assigned to the wait-list control group until after the study. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child with BMI ≥ 85th percentile for age and sex
- Child is accompanied by a parent or legal guardian
- At least one member of the family have to be able to speak and read English
- Family agrees to attend group meetings over 10 weeks
Key exclusion criteria (3 listed)
- Child unavailable to attend group weekly sessions
- Parent or guardian unavailable to attend group weekly sessions
- Participating child or parent, according to parent report, has medical condition contraindicating mild energy restriction or moderate physical activity, and medical clearance was not obtained
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 |
|---|---|---|
| Family Healthy LivingChildren aged 8-12 and at least one caregiver will meet for 10 weekly intervention sessions (1.5 hours per session), and 4 extra sessions to be chosen by families and intervention Leaders. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. Four biweekly maintenance sessions will follow the main program. | Behavioural | Family Healthy Living Intervention |
Primary outcome
Changes in BMI calculated from measures of height and weight
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Measures of height and weight will be obtained from all children. BMI will be calculated as weight (kilograms) divided by height (meters) squared, adjusted for child age and sex.
31 secondary outcomes
Changes in BMI z-score calculated from measures of height and weight
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C)
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Motivation and Confidence assessed by the Canadian Assessment of Physical Literacy (CAPL-2) Physical Activity Motivation and Confidence subscale
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Fundamental Movement Skills (FMS) assessed by the Canadian Agility and Movement Skill Assessment (CAMSA)
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Dietary Behaviours assessed by the LiGHT questionnaire (7-day recall questions retrieved from CDC BRFSS surveys)
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Healthy Eating Outcome Expectations assessed by the Power Play! Survey.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Self-esteem assessed by the Project EAT survey
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Gratitude assessed by the Gratitude Adjective Checklist
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Self-compassion by the Self-compassion Scale Short Form
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Sleep Habits assessed by the FLASHE questionnaire
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Structure of the Home Food Environment assessed by the Fruit and Vegetable At Home Survey For Parents.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent's Personal Dietary Behaviours are assessed by the FLASHE questionnaire.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Food Preparation Self-efficacy assessed with two questions drawn from the FLASHES-EAT survey.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Behavioral Regulation of Supporting Child's Healthy Eating assessed by the Action Control of Parent Support Behaviour
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Habits assessed by the automaticity subscale of Self-Report Index of Habit.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Behavioral Regulation of Supporting Child's Physical Activity assessed by the Action Control of Parent Support Behaviour
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Habit assessed by the automaticity subscale of the Self-Report Index of Habit
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Support for Child Sleep Habits assessed by the ParticipACTION 24hr Guidelines Survey
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Child Quality of Life assessed by the Pediatric Quality of Life Inventory
Time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 33370164Perdew M, Liu S, Rhodes R, Ball GDC, Masse LC, Hartrick T, Strange K, Naylor PJ. The Effectiveness of a Blended In-Person and Online Family-Based Childhood Obesity Management Program. Child Obes. 2021 Jan;17(1):58-67. doi: 10.1089/chi.2020.0236. Epub 2020 Dec 23.
- Derived from this study: PubMed 31676642Liu S, Marques IG, Perdew MA, Strange K, Hartrick T, Weismiller J, Ball GDC, Masse LC, Rhodes R, Naylor PJ. Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. BMJ Open. 2019 Oct 31;9(10):e027183. doi: 10.1136/bmjopen-2018-027183.
- Individual participant dataSharing planned: No. Individual participant data will only be share with co-investigators
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Karen Strange, PhD study director
Childhood Obesity Foundation
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Healthy Living in people with Obesity and Health Behavior, run by University of Victoria at 10 sites in Canada.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patti-Jean Naylor, PhD (250-721-8373, pjnaylor@uvic.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BMI calculated from measures of height and weight (time frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)). 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 NCT03643341, which also lists 2 linked publications.
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 9 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.