EAL

NGHC: Prevention of Chronic Disease (2013)

Citation:

Fulkerson JA, Rydell S, Kubik MY, Lytle L, Boutelle K, Story M, Neumark-Sztainer D, Dudovitz B, and Garwick A. Healthy home offerings iva the mealtime environment (HOME): Feasibility, acceptability and outcomes of a Pilot study. Obesity. 2010; 18 (1): S69-S74.

PubMed ID: 20107464

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

Primary purpose: To develop, implement and test the feasibility and acceptability of the HOME program.
Secondary purpose: To acquire preliminary data that would support the design of a larger trial.

Thus, the study proposes that by the end of a three-month period, the experimental households would have more fruits and vegetables and fewer high-fat foods and high-sugar foods and beverages available in the home and served at family meals–compared to the control group families. Children in the experimental group would have higher fruit and vegetable consumption, lower fat and sugar intake, and lower age and gender specific body mass index (BMI) percentile values compared to children in the control group.

Inclusion Criteria:

Parent/child dyads were recruited from two elementary schools/after school programs in the Minneapolis, MN area
The targeted parent was the person who prepared most of the household meals and the child was an individual between the ages of eight to 10 years
Other criteria included:
- Agreement to follow the study protocol
- Workshop attendance
- Ability to speak English.

Exclusion Criteria:

Children were ineligible if they were:

Very underweight
Had conditions that would affect intervention program participation
Did not speak English.

Description of Study Protocol:

Recruitment

Parent/child dyads were recruited via flyers, school newsletters, and small group presentations
After-school program staff were hired on a limited basis to aid recruitment efforts and provide childcare services during the intervention sessions.

Design

Randomized control trial (pilot study).

Dietary Intake/Dietary Assessment Methodology

24-hour dietary recalls
Home food inventory
Family meal inventory.

Blinding Used

Not applicable.

Intervention

Assessments were conducted with all families in their homes at three times (baseline, post-intervention, and six-month follow-up)

Statistical Analysis

Process measures of dose and fidelity were evaluated using frequencies. Frequencies of parent and child satisfaction were calculated to assess program acceptability
Statistical comparisons of the data were performed to determine between group differences in outcomes (adjusted for baseline levels).

Data Collection Summary:

Timing of Measurements

Baseline
Post-intervention
Six-month follow-up data.

Dependent Variable

Psychosocial surveys
Anthropometry (children's measurements)
24-hour recalls
Home food availability
Meal offering inventories.

Independent Variables

Healthy home offerings mealtime environment (HOME) nutrition education program

Control Variables

Not applicable.

Description of Actual Data Sample:

Initial N: 44 parent/child dyads
- 48% male children
- 52% female children
Attrition (final N): 100% of the 44 families completed the program
Age:
- Eight- to 10-year-old children
- Parental age: 41.5 years with a standard deviation (SD) of 5.3 years
Ethnicity:
- Children:
  - 84% white
  - 11% mixed race
  - 5% Native American
  - 2% African American
- Parents:
  - 86% white
  - 7% mixed race
  - 5% Native American
  - 2% African American
Other relevant demographics: 75% college educated parents
Anthropometrics: 30% overweight children as evidenced by greater than 85th percentile for BMI ranking
Location: Vicinity of Minneapolis, MN.

Summary of Results:

Primary Findings

All the families completed all the home assessments. 86% of the intervention families attended at least four of the five educational sessions. Parents and children were very satisfied with the program, with 95% of the parents and 71% of the children rating sessions as follows:

Four or five on a scale of 1-5
Family homework completion was also successful (all five (N=6), four (N=8) one to three (N=4) and one (N=4).

Other Findings

Secondary aims:

Families in both groups reported an average of five family dinners per week at post-intervention. At post-intervention children in the experimental group were significantly more likely than children in the control group to report gaining food preparation skills. Also, trends for greater parental report of child food preparation skills and reports of improvement in self-efficacy regarding meal preparation were trending in the expected direction. The parents in the experimental group also reported that there children were helping to make dinner more often than the children in the control group.
There were favorable trends emerging regarding higher fruits and vegetables, Availability and intake, lower availability of quick, high-fat MW foods and processed meats in the intervention homes vs. control homes. Other changes included less sweetened beverage and high-sugar cereal intake. Vegetable and salad intake also improved in a favorable direction. Positive nutrient outcomes were evident and in the expected direction, including reductions in percent of calories from fat, and increases in fiber, calcium, and vitamins B₆ and B₁₂. At post-intervention, children in the intervention group did not have significantly lower BMI percentiles or BMI z-xcores compared to children in the control groups.

Author Conclusion:

Obesity prevention programs with families in community settings is feasible and well-accepted
The home visits were valued by both control and intervention families
Inviting the entire family to participate increased program retention
Childhood obesity research partnerships may be beneficial to several collaborating organizations and participants.

Reviewer Comments:

None.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes