Guelph Family Health Study: Pilot Study | NCT02223234

Studies
Guelph Family Health Study: Pilot Study

NCT02223234

Sponsor

University of Guelph

Status

Completed

Last Update Posted

Jan 4, 2017Estimated

Enrollment

44Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Emails and 4 Home Visits
Control
Emails and 2 home visits

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Aug 20, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2017

Last Update Posted Date

Jan 4, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jess Haines, Associate Professor, University of GuelphPrincipal Investigator

Lead Sponsor

University of GuelphOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.

To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.

We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:

a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.
higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)
lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.

We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Control- monthly mailed information on children's health	Behavioral: Control
Email and 4 Home Visits	Experimental	Weekly emails and 4 home visits with a health educator	Behavioral: Emails and 4 Home Visits
Email and 2 Home Visits	Experimental	Weekly emails and 2 home visits	Behavioral: Emails and 2 home visits

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emails and 4 Home Visits	Behavioral	Weekly emails and 4 home visits with health educator	Email and 4 Home Visits

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in adiposity		baseline, 6 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
change in body mass index		baseline, 6-month follow-up
change in waist circumference		baseline, 6-month follow-up
change in frequency of family meals

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

families who have a child aged 18 months through 5 years
live the Guelph area
have a parent who can respond to questionnaires in English

Exclusion Criteria:

families who plan to move during the study period
children with severe health conditions (such as severe cerebral palsy) that would prohibit them from participating in study activities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy of Guelph		Guelph	Ontario	N1G 2W1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30873285	Derived	Krystia O, Ambrose T, Darlington G, Ma DWL, Buchholz AC, Haines J; Guelph Family Health Study. A randomized home-based childhood obesity prevention pilot intervention has favourable effects on parental body composition: preliminary evidence from the Guelph Family Health Study. BMC Obes. 2019 Mar 4;6:10. doi: 10.1186/s40608-019-0231-y. eCollection 2019.
29981086

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases