EAL

HD: Effectiveness of Nutrition Intervention Methods (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of the study was to evaluate a community health nurse or peer counselor intervention to increase the duration of breastfeeding among low-income, predominately minority women during the first six months of their infants' lives. The costs of the intervention, health care and formula for the child were also evaluated.

Inclusion Criteria:

Low income women (receiving financial medical assistance support)
Post-partum; delivery of full-term singleton infant.

Exclusion Criteria:

Exclusion criteria were not described.

Description of Study Protocol:

Recruitment

Research assistant approached women during post-partum hospitalization at a large academic medical center.

Design

Participants responded to several questionnaires after signing an informed consent form
They were then assigned randomly to an intervention or usual care group
Interviews were conducted in the hospital room or at home
Infant data outcomes were collected in person at months three and six and by telephone at post-partum weeks one, two, three, four and six and at month four
Mother was contacted by telephone at least every two weeks to determine breastfeeding duration and potential cost savings.

Intervention

Participants in both groups received usual breastfeeding support:
- Support from hospital nurses
- Assistance by means of a telephone "warm line"
- One hospital visit by a lactation consultant if the participant delivered on a weekday
Intervention group also received:
- Daily visits from the community health nurse or peer counselor team during hospitalization
- Home visits from the team during weeks one, two and four and at the team's discretion
- Telephone support twice weekly through week eight and weekly through month six (even if the mother stopped breastfeeding).

Statistical Analysis

Statistical methods were not described.

Data Collection Summary:

Timing of Measurements

Interviews conducted in the hospital room or at home
Infant data outcomes collected in person at months three and six and by telephone at post-partum weeks one, two, three, four and six and month four
Mother contacted by telephone at least every two weeks to determine breastfeeding duration and potential cost savings.

Dependent Variables

Breastfeeding duration (number of weeks)
Costs of:
- Formula (based on quantity mothers reported using and price data obtained from national drug store)
- Intervention (based on number of contacts, length of contacts, number of attempted contacts, mileage, driving times, salaries and standard mileage estimates)
- Indirect costs (including time for feeding, calculated using mothers' wage based on their reported occupations, using data from the National Compensation Survey or average weekly earnings for individuals by education level)
Number of health care services used:
- Checkups
- Sick visits
- Prescriptions
- Immunizations
- Emergency department visits
- Total hospitalizations.

Independent Variables

Treatment (intervention vs. usual treatment).

Description of Actual Data Sample:

Initial N

41 mothers:

21 in intervention group
20 in usual care.

Attrition (Final N)

Authors do not describe any attrition; unclear if all participants who started study completed it.

Age

Average age in years (SD):

Intervention group: 20.86 (3.58)
Usual care: 22.35 (4.98).

Ethnicity

African American:

Intervention group: 95.2%
Usual care: 90.0%.

Other Relevant Demographics

Education (12 or more years):
- Intervention group: 81.0%
- Usual care: 88.9%
Single:
- Intervention group: 81.0%
- Usual care: 100.0%
Breastfeeding goals in weeks (SD):
- Intervention group: 30.7 (17.2)
- Usual care: 29.4 (17.8).

Anthropometrics

Infant's mean birth weight in grams (SD):

Intervention group: 3,089.6 (417.9)
Usual care: 3,387.2 (424.4).

Location:

Mid-Atlantic region of the United States.

Summary of Results:

Key Findings

Variables	Intervention Group N (%)	Usual Treatment N (%)	Statistical Significance of Group Difference
Exclusively breastfeeding at three months	9 (45)	5 (25)	NS
Exclusively breastfeeding at six months	6 (30)	3 (15)	NS
At least partially breastfeeding at six months	9 (45)	7 (35)	N/A

NS=not statistically significant.

N/A=not available.

Other Findings

Average Costs and Benefits per Mother

Variables	Intervention Group Average [SE]	Usual Treatment Average [SE]	Difference Average [SE]
Formula	$438 [77]	$685 [75]	($247) [107]
Intervention	$301	--	$301
Indirect costs (cost of time spent feeding)	$3,101 [173]	$2,509 [188]	$592 [255]
Total costs	$3,840 [202]	$3,194 [149]	$646 [251]*

SE=standard error.

Numbers in parentheses are negative.

*Statistically significant (P<0.05).

Average Health Care Services Use per Infant

Variables	Intervention Group Average [SE]	Usual Treatment Average [SE]	Difference Average [SE]
Total visits	3.6 [0.28]	5 [0.53]	-1.4 [0.6]*
Sick visits	0.45 [0.15]	1.2 [0.33]	-0.75 [-0.36]*
Prescriptions	0.25 [0.12]	0.85 [0.27]	-0.6 [0.30]*

SE=standard error.

*Statistically significant (P<0.05).

No significant difference seen between groups in:

Checkups
Immunizations
ER visits
Total hospitalizations.

Author Conclusion:

Community health nurse and peer counselor support can increase breastfeeding duration in low-income women, and has the potential to reduce total costs, including the cost of support. A better understanding of the costs incurred to conduct this program and the economic valuation of benefits will help decision-makers in allocating resources to improve the health and quality of life for mothers and infants.

Funding Source:

Government:

National Institute of Nursing Research

Reviewer Comments:

Despite their conclusion, the authors of this study do not have the statistical evidence that their intervention increased breastfeeding duration; their study may not have had a large enough sample to show evidence of effectiveness. The intervention was more costly than usual care, but the authors discussed the limitations in interpreting this evidence and the need for further economic valuation of benefits.

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)	???
	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?	???
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?		???
	4.1.	Were follow-up methods described and the same for all groups?	No
	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	???
	4.4.	Were reasons for withdrawals similar across groups?	???
	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?		???
	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?	N/A
	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?	???
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	???
	6.6.	Were extra or unplanned treatments described?	???
	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?		???
	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?	???
	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?	No
	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?		???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	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