Preventing Obesity Through Parent Empowerment and the Activation of Routines (PrO-PEAR)

Down Syndrome Clinical Trial

— PrO-PEAR  

Official title:

Preventing Obesity Through Parent Empowerment and the Activation of Routines (PrO-PEAR) Optimization and Feasibility: A Pilot Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020366
• Other study ID #: STUDY21040155
• Secondary ID: 5K12HD055931-14
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: May 23, 2023

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the feasibility of the Preventing Obesity through Parent Empowerment and the Activation of Routines (PrO-PEAR) intervention using a open case-series for intervention optimization followed by a pilot RCT in which participants are randomized to receive PrO-PEAR or enhanced usual care (EUC).

Specific aims include:

1. Optimize the PrO-PEAR intervention manual using an open case series with iterative stakeholder feedback.

2. To determine the feasibility of the PrO-PEAR intervention in terms of recruitment, randomization, retention, adherence, and acceptability.

3. Estimate the effects of the PrO-PEAR intervention on parent reported child health behaviors in each Institute of Medicine obesity prevention area (nutrition, physical activity, sedentary behavior, sleep) over time as compared to a control group.

The following benchmarks will be used to determine feasibility:

Recruitment: >3 parent/child dyads per month Retention: >75% of consented dyads will complete > 8 sessions Adherence: >80% clinician protocol adherence during 100% of sampled sessions Data Collection: >80% planned assessments collected among intervention completers.

Acceptability: >90% of parent intervention completers rate intervention as acceptable.

Additionally, it is predicted that parents will report greater gains in the areas of nutrition, sleep, sedentary behavior and physical activity in the PrO-PEAR group than those in the control group.

Description:

Interested participants will contact the research team and screening to determine eligibility may be confirmed in person or over the phone. Interested parent participants will undergo the consent process with a trained research assistant and/or the principal investigator. Families will be sent the informed consent documents prior to informed consent process. Prior to data collection, a member of the research team will use a script to discuss the risks and activities involved in study participation and answer any questions the participant has about the study. Following signed informed consent, an appointment will be scheduled for baseline assessments.

Child participants will be provided with the wrist-worn actigraphy device and thigh-worn Physical Activities Logging (activPAL) device, and parents/caregivers educated on the wear schedule and periodic skin checks to ensure skin integrity. Parents will be instructed to complete skin checks daily to minimize risk of abrasions and to contact the study team immediately if any issues occur. The child will wear these devices to collect data on activity, sedentary behavior, and sleep for 7 full days. It is anticipated that each assessment appointment will last approximately 2 hours. If conducted remotely, devices and other materials will be mailed to the participant and completed with a member of the research team on the phone or video conference to answer any question. Equipment will be collected at the time of the first in- person intervention session or by placing in a pre-paid postage box (provided by research team) and placing in the mail.

After assessments, the first approximately ten families will receive the PrO-PEAR intervention from Caldwell (PI) over 12 sessions in their home. Every other week (weeks: 1, 3, 5, 7, 9, 11) parents will be coached on a new health promoting topic: family meals, healthy portions, bedtime routines, strategies for screens, moving and grooving, and health promoting play. Each of these sessions will last approximately 30 minutes and may be delivered in person or remotely (using Zoom). During the alternate weeks (2, 4, 6, 8, 10, 12) therapists will check in with families and address any issues or barriers (such as child behavior) that has impacted progress toward building healthy habits. Each of these sessions will last approximately 30 minutes and be delivered remotely via Zoom.

Data collected from these first ~10 families will inform intervention optimization and finalization of the manual of procedures for the pilot RCT. Once the manual is finalized, 24 additional families will be recruited and randomized (2:1) to receive either PrO-PEAR or a control (enhanced usual care). Families assigned to PrO-PEAR will receive intervention as described above with minor modification as informed by the first 10 participants. PrO-PEAR will be delivered by trained occupational therapy clinicians. Families assigned to control will receive enhanced usual care. Enhanced usual care will include information about child habits in the areas of healthy eating, physical activity, sedentary behavior and sleep based on parent questionnaires and actigraphy. For both the PrO-PEAR and the control group, usual care will be documented through questions about receipt of services and semi-structured interviews with parents.

Parent Experience:

All research activities will take place in the participants' homes. Parents will be expected to complete assessment and intervention activities in the comfort of their home with the research team joining in-person or virtually as needed/preferred. They may refuse to participate in any portion of the research study at any time and will be encouraged to be an active collaborator throughout all actives.

Child Experience:

Children will be expected to wear the Phillips Actiwatch on their wrist and the activPAL on their thigh for 1 week at each assessment timepoint. Children will be expected to participate in activities initiated by their parents and clinicians as appropriate throughout all phases of research.

Based on prior studies within the lab, it is anticipated that >75% of participants will complete the 3-month program and 6 month follow-up (>18/24). A sample size of 24 in the pilot RCT will provide us with the >12 PrO-PEAR intervention completers needed to estimate average outcome values and variability to plan larger subsequent trials.

Descriptive statistics will be used to determine whether feasibility benchmarks have been met for each group. Between group differences and differences in primary outcomes over time will be analyzed using linear mixed models with fixed and random effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

Child Inclusion Criteria:

1. between the ages of 12 and 36 months

2. diagnosis of Down syndrome

3. demonstrate independent mobility (e.g., walking, crawling)

Child Exclusion Criteria:

1. mobility is significantly restricted because of a medical condition, or

2. nutrition is received primarily by feeding tube.

Parent Inclusion Criteria

1) aged > 18 years

Parent Exclusion Criteria

• N/A

Related Conditions & MeSH terms

• Down Syndrome

Intervention

Behavioral:
• Preventing Obesity through Parent Empowerment and the Activation of Routines
Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
• Enhanced Usual Care
For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.

Locations

Country	Name	City	State
United States	Down Syndrome Center of Western Pennsylvania	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of PrO-PEAR intervention sessions completed	As measured using interventionist documentation	3 months
Primary	Parent-reported intervention acceptability as rated on a Likert scale.	Participant acceptability ratings of the PrO-PEAR intervention using the Treatment Acceptability Questionnaire. Scores range from 8 to 48 with higher scores indicating higher acceptability.	3 months
Primary	Percentage of planned data collection efforts completed successfully	Measured by the number of outcomes collected divided by the number of planned outcomes	6 months
Primary	Number of participant families recruited per month	Quantified for each month of active recruitment and averaged	up to 1 year
Primary	Interventionist fidelity to treatment protocol	Measured using a checklist of items in the protocol for each session and quantified by percentage that were met.	3 months
Secondary	Change in Healthy Eating from Baseline to 3 months	change in # of fruits & vegetables children consumed, on average, each day as measured by parent report and written logs	baseline to 3 months
Secondary	Change in Healthy Eating from Baseline to 6 months	change in # of fruits & vegetables children consumed, on average, each day as measured by parent report and written logs	baseline to 6 months
Secondary	Change in Physical Activity from Baseline to 3 months	change in # of hours of light, moderate, or vigorous child physical activity, on average, each day as measured by activPAL	baseline to 3 months
Secondary	Change in Physical Activity from Baseline to 6 months	change in # of hours of light, moderate, or vigorous child physical activity, on average, each day as measured by activPAL	baseline to 6 months
Secondary	Change in Sedentary Behavior from Baseline to 3 months	change in # of child bouts of sedentary behavior >60 minutes, on average, each day as measured by activPAL (Physical Activities Logging)	baseline to 3 months
Secondary	Change in Sedentary Behavior from Baseline to 6 months	change in # of child bouts of sedentary behavior >60 minutes, on average, each day as measured by activPAL	baseline to 6 months
Secondary	Change in Sleep Quality form Baseline to 3 months	change in # hours of quality child sleep, on average, each day as measured by the Phillips Actiwatch	baseline to 3 months
Secondary	Change in Sleep Quality form Baseline to 6 months	change in # hours of quality child sleep, on average, each day as measured by the Phillips Actiwatch	baseline to 6 months
Secondary	Change in Child Weight from Baseline to 6 months	Child weight will be assessed using chart review and scale	baseline to 6 months
Secondary	Change in Child Weight from Baseline to 1 year	Child weight will be assessed using chart review and scale	baseline to 1 year
Secondary	Change in Child Height from Baseline to 6 months	Child weight will be assessed using chart review and scale	baseline to 6 months
Secondary	Change in Child Height from Baseline to 1 year	Child weight will be assessed using chart review and scale	baseline to 1 year