NCT02202733

Brief Summary

The primary goal of the study is to use an iterative process to develop and refine a skill-based cooking intervention to decrease the consumption of energy from foods prepared away from home for evening meals, decrease energy intake, and promote a healthy weight in parents and children aged 3-10 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

July 25, 2014

Last Update Submit

July 13, 2015

Conditions

Keywords

cooking skillseating outfoods prepared away from home

Outcome Measures

Primary Outcomes (1)

  • Dietary Intake (Phase II only)

    Caregivers will be asked to complete a 7-day dietary record of what they and their child eat at the evening meal. For each evening meal, the caretaker will be asked to describe the meal type (fast food, restaurant, pre-prepared frozen meal, or home prepared); the specific foods and drinks consumed, and the amount consumed by the child. Data from dietary records will be input into Nutrition Data System for Research (NDSR) software and analyzed for energy intake, percent energy from fat, and food groups (fruits, vegetables, grains, proteins, dairy) from the evening meal. Foods prepared away from home will be classified based on caretaker indication of fast food, restaurant, pre-prepared frozen meal, or home prepared on the dietary record.

    0 and 10 weeks

Secondary Outcomes (5)

  • Caretaker Attitudes and Confidence

    0 and 10 weeks

  • Food Costs

    0 and 10 weeks

  • Portions

    0 and 10 weeks

  • Dinner Choices

    0 and 10 weeks

  • Anthropometrics

    0 adn 10 weeks

Study Arms (1)

Cooking

OTHER

A skill-based cooking intervention for caretakers of an overweight/obese child aged 3-10 years.

Other: Cooking

Interventions

CookingOTHER

The aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status.

Cooking

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • be ≥18 years of age
  • have a child between the ages of 3 and 10 years-old
  • report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper
  • able to read, speak, and understand English
  • have transportation to the Medical Center
  • report their family including the child eats pre-prepared frozen food, restaurant food, fast food, or take-out for dinner ≥3 times per week
  • has a working telephone number
  • is able to attend the scheduled date and time of a focus group.
  • caretaker is ≥18 years of age
  • caretaker is overweight or obese (BMI≥25)
  • has a child between the ages of 3 and 10 years-old
  • report being the primary caretaker and have the primary feeding responsibility of the child for dinner/supper
  • caretaker is able to read, speak, and understand English
  • has transportation to the medical center and the instructional kitchen
  • does not plan to move out of the area before June 2015
  • +3 more criteria

You may not qualify if:

  • the caretaker or child is currently participating in a weight loss program and/or taking weight loss medication
  • have a medical condition known to promote growth (e.g., Prader-Willi syndrome, Cushing's syndrome) or had gastric bypass surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Cooking

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 29, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations