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2 Research Center on Nutrition and Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico and 3 Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853
* To whom correspondence should be addressed. E-mail: bonvecchio{at}insp.mx.
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ABSTRACT |
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 TOP ABSTRACT IntroductionMaterial and MethodsResultsDiscussionLITERATURE CITED |
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Introduction |
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TOPABSTRACTIntroductionMaterial and MethodsResultsDiscussionLITERATURE CITED |
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Our study was undertaken as part of the "mission-oriented research" that was built into the Oportunidades Program to investigate obstacles to applying nutritional and public health interventions (3,4). A previously randomized evaluation of program effectiveness found statistically significant effects on the nutritional status of children in households that participated in Oportunidades (5), but the magnitude of the effect was less than expected, given the amount of supplement received by the households. A likely explanation was identified in a subsequent investigation, which suggested that household utilization behaviors with respect to papilla were inadequate (6).
This article presents the results of an intervention study that was undertaken to determine whether improvement in household supplement utilization could be achieved with a communication intervention developed within the Oportunidades Program that could potentially be implemented on a large scale.
Prior to the trial, a content and delivery strategy for the intervention were developed through an extensive formative research process, involving both qualitative and quantitative data collection procedures (6). Information was collected to understand mothers' and health care providers' concepts and to facilitate decisions about the target audience and the types of messages and communication channels that were needed for the design of culturally appropriate behavioral change strategies. The formative research revealed that mothers typically mixed papilla with a substantial amount of water to create a thin drink rather than giving it as a pap, and that a major reason for not giving it daily was that the ration was used up before the end of the month. The explanation for the shortfall was that mothers commonly prepared it more than once a day, gave it as a main meal instead of as a food supplement, and gave it to other children in the family in addition to the target child.
Based on the formative research study, 4 behaviors were identified and the messages to promote them were formulated as follows: 1) prepare papilla with 4 tablespoons (59.2 mL) of the powder and 3 tablespoons (44.4 mL) of water; 2) give papilla to your child every day; 3) give papilla to your child between meals, specifically between breakfast and dinner (the comida, which is best translated as dinner, is the main family meal, which usually is eaten in early or mid afternoon), and 4) give papilla only to target children.
After the messages were defined, a variety of visual and audio materials were developed. These included posters, flyers, counseling aids for outreach workers, and briefing packages for health care personnel. In addition to the briefing package, a video was created for them, providing the rationale for the messages and tips on counseling mothers about correct supplement use. In Chiapas, where language barriers between health workers and mothers may be a constraint, a video directed to mothers, in their native language of Tsolsil, was provided to health centers.
Three communication channels were used to introduce the 4 messages to households and to motivate behavior change: local community volunteers, health care service providers, and mass media. Local community volunteers visited every household and conducted demonstrations of the correct preparation of papilla. Health care service providers talked to mothers, and the videos were shown in the waiting room. Posters were mounted in multiple sites, including health centers, stores, community centers, and churches. Megaphones, mounted on trucks and cars and commonly used thorough out Mexico to broadcast messages and announcements, were also used.
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Material and Methods |
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TOPABSTRACTIntroductionMaterial and MethodsResultsDiscussionLITERATURE CITED |
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Study design: units of randomization and subjects. This study was approved by the Ethic Committee of the National Institute of Public Health, Cuernavaca, Morelos, Mexico. We used the cluster randomized trial (7), probability design (8) with random assignment to intervention and control conditions, and pre- and postevaluation to assess change in household behaviors. The sampling frames and sample selection of the communities and households were conducted according to CONSORT recommendations (7) (Table 1). Within the states, the municipio is the administrative unit; a municipio contains named settlements (communities) that vary in size from towns to villages to small hamlets of a few households. This table indicates the extent of the Oportunidades Program in Veracruz and Chiapas, showing that most but not all municipios have recipient communities, and not all communities within recipient municipios were eligible for the Oportunidades Program. From a list of the 7352 communities in Veracruz that received the Oportunidades Program, we selected an index community and then paired it with another community on the basis of socio-economic characteristics. Within each pair we randomly selected 1 of 2 communities (by drawing numbers from a hat) to receive the treatment. The other matched community served as the control group. We then identified and interviewed the eligible households in these communities and in immediately adjacent communities to achieve the desired sample sizes. We followed the same procedure in Chiapas, except that we included, in the initial sampling frame, only Tsotsil-speaking communities (n = 805) that received the Oportunidades Program. This sampling procedure guaranteed that the assessed impact could be attributed to the intervention at a stated level of significance (e.g., P < 0.05).
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Data collection. At baseline, prior to the implementation of the intervention, informed consent was obtained and interviews with the primary caregiver were conducted using a structured interview schedule. The interview included information on household demographic and socio-economic characteristics and preparation of the supplement and its consumption by household members. A 24-h recall and FFQ were applied to obtain information on the index child's diet, from which one could ascertain the degree to which the supplement was given daily and the time of day it was given. The follow-up survey to assess behavior change was conducted after the intervention had been running for 5 mo. In the follow-up survey, questions were repeated regarding the preparation and household consumption of the supplement and on the diet of the index child. Interviewers were trained and standardized to administer the data collection instruments. In Chiapas, where all the interviews were conducted by bilingual fieldworkers in Tsotsil, there was additional training on issues related to translation.
Observational substudy. An observational substudy was designed to obtain detailed data on how caregivers were applying the recommendations promoted through the communication channels. These observational records also provided an opportunity to compare the behaviors reported to the survey interviewers with caregivers' actual behaviors. Thirty-eight households (20 in Veracruz, 18 in Chiapas) were randomly selected from the follow-up survey data base, using a random numbers table. Of these, complete observational records, consisting of 2 d of consecutive 6-h observations, were available for 23 households. Fieldworkers, who were recruited and trained specifically for this substudy, collected information with a structured checklist and wrote open-ended field notes. The research was explained to participants as a study to better understand child care, without any specific mention of food or feeding, and observations were conducted by fieldworkers who had not been involved in the surveys.
Statistical methods. The prevalence of correct answers in the baseline (before) and in the final (after) survey were estimated for each of the 4 clusters of communities for each of the 4 behaviors. The differences presented in this study were assessed for statistical significance using t tests. Binomial t tests, using the household as the unit of analysis, were used for the descriptive statistics as follows: the differences between the intervention and control clusters of communities were assessed separately for the baseline and the final survey within each of the 2 states (Veracruz and Chiapas). The before and after difference (change) in prevalence were then assessed within each cluster of communities.
To estimate the causal impact of the intervention one must take into account that households within the communities in a cluster can be different from those in another cluster for many reasons other than because they received an intervention. Also, households in a cluster are more likely to be similar to each other than households across clusters. Therefore, we estimated the probability of a causal impact using the cluster (not the household) as the unit of analysis, thus avoiding the effects of clustering on the statistical analyses. The magnitude of the causal impact can be estimated by a double-difference procedure (see Table 2). The changes in the intervention and control groups in prevalence between the before (b) to after (a) surveys measure change; these are the 1st differences, 
b and a. The difference (b – a) between the control and intervention groups is the 2nd difference, . Conversely, the differences of prevalence between intervention (I) and control (C) within the 2 surveys are the 1st differences: I and C. The difference (I – C) between the baseline and final surveys is the 2nd difference, . Both 2nd differences are identical. The 2nd difference is the increase in prevalence that is due to the intervention. The impact of the intervention is the 2nd (double) difference, .
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Within the intervention communities, all households were exposed to the intervention to some degree, but, inevitably, the degree of exposure varied. Because this study was concerned about the total effect at whatever the level of exposure, we analyzed the data according to "intent to treat," including all households in the intervention baseline sample. The estimate of impact was therefore lower than if we had estimated the effect of the intervention only in those who were fully exposed to it.
Given the probability design of the trial, further testing for confounding was not necessary to confirm the significance of the causality of impact. However, we did check whether substantial differences in baseline maternal and child characteristics might warrant further plausibility analyses (8). To examine this, we calculated the differences across the states of the differences between the intervention and control groups within states. This t test also has 1 degree of freedom.
The method for examining concordance of reported and observed behaviors in the substudy was as follows: the proportion of observed households that followed the recommended behavior was divided by those that reported the behavior, which resulted in a measure of the proportion who reported correctly. The corresponding lower 95% CI of this proportion was estimated using the appropriate t statistic with the binomial standard error.
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Results |
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TOPABSTRACTIntroductionMaterial and MethodsResultsDiscussionLITERATURE CITED |
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Message 2 was to give papilla to the child every day. Again, a high proportion (78.2–71.6%) of the women in the intervention groups followed this recommendation, compared with 17–22.2% of the women in the control groups. This was a many-fold increase from baseline, compared with no increase in the control groups. The mean increment across both Veracruz and Chiapas was 64.4% (t test: 7.0, P < 0.05) compared with controls.
Message 3 directed caregivers to give papilla as a specially prepared snack between breakfast and dinner, rather than as part of a meal. Based on the final 24-h recall, which, like the baseline survey, included information on the time of day when every food item was consumed, behavior improved markedly. The mean increment across both states was 61.5% (t test: 16.3, P < 0.05) compared with the control.
The 4th recommendation was designed to encourage women to give papilla only to target children. In Veracruz, where correct preintervention behavior was reported by about half the sample, the proportion who reported correct preparation procedures rose>90% in the intervention group and remained unchanged in the control group (P < 0.001). In Chiapas, initial rates were low and showed a modest improvement in both the intervention and control groups in the follow-up survey. The probability analyses in the arc-sin transformation did not show a consistent effect of the intervention across both Veracruz and Chiapas, which conforms to the lack of effect in Chiapas.
The influence of maternal and child characteristics across treatment and control groups resulted in values <1.38, that is, with low significance (P > 0.40). These t test values were many-fold lower than results of analyses ascertaining the causality of response to the intervention for messages 1, 2, and 3, which indicated that there was no need to take these characteristics into account in interpreting the impact of the intervention.
How households changed or remained constant in their papilla behaviors is information that cannot be derived from Figure 1 or the statistical demonstration of impact (Table 4). Care-givers were classified on the basis of the change from baseline to follow-up evaluation. Four mutually exclusive categories were created: 1) adequate initial and final behavior, 2) from inadequate (initial) to adequate (final) behavior, 3) inadequate initial and final behavior, and 4) from adequate (initial) to inadequate (final) behavior. Table 4 presents the proportions of caregivers in each subgroup for each recommended behavior. It documents the level of uniformity of change among those who received the intervention and the level of stability among those who did not. For example, for behavior 1 (correct preparation) 12 (7%) and 15 (8%) women in the intervention groups of Veracruz and Chiapas, respectively, shifted from initially adequate behavior to inadequate, despite receiving the intervention. Overall, backward slippage across the 4 behaviors was 4.1% in Veracruz and 6.2% in Chiapas, compared with 10.0 and 14.5% in the control groups. There was considerable behavioral stability among controls; depending on the specific behavior, between 71 and 93% of women did not report modifications to their behavior from baseline to follow-up, and the mean across the 4 behaviors was 77.6%.
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Discussion |
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TOPABSTRACTIntroductionMaterial and MethodsResultsDiscussionLITERATURE CITED |
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Knowledge and behavior are, of course, two different dimensions of human experience, and this study does not provide definitive evidence that the intervention was effective in actually improving supplement use. However, the internal consistency of responses in the intervention group and results of the observation substudy suggest that maternal behaviors, and not just knowledge, were affected by the intervention. The formative research prior to the design of the intervention revealed that a major reason for not giving papilla daily was that the ration was used up before the end of the month. A primary goal of the intervention, which is reflected in the recommendations, was to reduce "leakage" of the supplement to other family members. Unless women were consistently misreporting on the follow-up survey, the sharp increase in the number of mothers who reported giving papilla daily could only have occurred if they were preparing it as recommended, and were directing it mainly to the target child rather than as an ingredient in the family diet (e.g., as an ingredient in the common family breakfast drink, atole). The agreement between women's responses on the survey and the behaviors that were observed in the substudy households is also encouraging, particularly because considerable efforts were made to avoid the likelihood that mothers would link the observers with the Oportunidades Program or the intervention.
In control groups of both states, there was a modest but consistent downward trend in the numbers of mothers who reported adequate behavior at baseline compared with follow-up, with the exception of recommendation 4 in Chiapas. However, as the results indicated, the level of stability in papilla-related complementary feeding in the control group was relatively high (Table 4). The extent to which this was true of complementary feeding practices generally, and not just the use of a supplement, requires further investigation as it has implications for research on complementary feeding practices and the design and evaluation of interventions.
In Veracruz and in Chiapas, with the exception of recommendation 4, all of the recommendations appear to be equally acceptable to mothers and equally easy to adopt, judging from the proportions of change in the follow-up survey (Fig. 1). The positive responses to the recommendations to prepare papilla as a pap and to administer it in mid-morning are particularly noteworthy in view of current concerns about barriers to behavior change. In both academic and programmatic discussions about improving complementary feeding practices there is concern that women who already have multiple pressures on their household management will not have the time or flexibility to add a special preparation or an additional feeding, nor will they readily accept a preparation that requires more active feeding than a liquid entails (9). Apparently the household responsibilities of the women in the intervention communities did not preclude behavior change in complementary care practices with respect to a prepackaged nutritional supplement.
The formative research was critical not only for problem identification and the development of recommendations concerning the specific behaviors to promote but it was also necessary for the formulation and presentation of messages and for writing the educational briefs for health that would help motivate participants to change. It is intriguing to note that the formative research provided an indication of the potential cultural constraints to behavioral change for recommendation 4 among the Chiapas. In the indigenous communities in the intervention group, the recommendation to administer the supplement only to target children (recommendation 4) was not acceptable to many of the mothers. In a focus-group discussion during formative research, a mother suggested that households should be provided with a supplement supply for all the children in a family, which she justified as follows: "When you have more than 1 child, and the 3 y- old (undernourished) is the only one that receives papilla, she is the only one that eats it, so the others start to cry. I feel sorry for them because we cannot give them the papilla... then I see that there is a problem. For this reason I think all the children in the family should receive the papilla." Other mothers voiced similar sentiments. The results from the evaluation indicate that this is a serious constraint that needs further attention when the communication intervention is scaled up. It also reinforces the notion that, in national programs serving different ethnic communities, recommendations and programs need to be adapted to local conditions.
For purposes of generalizing to other populations, an issue for future investigation is to examine the factors that facilitated a positive outcome. This type of study requires other kinds of data than were collected in this investigation. We hypothesize that the factors contributing to intervention success included that: 1) intervention was embedded within a larger, popular program; 2) the formative research revealed the specific aspects of household behavior that needed to be changed, as well as the motivations for nonideal behaviors, so that the communication program could be highly focused and consistently emphasize the specific behaviors that needed to be promoted; and 3) the intervention itself was carefully designed with adequate pretesting, and sufficient training, and motivating and monitoring of staff to ensure adequate delivery.
Translating nutritional science knowledge into better health for populations depends on the execution of a number of steps, each of which is crucial for realizing its potential. When public health intervention, derived from knowledge about nutrient requirements in children, involves a nutritional supplement intended to prevent or ameliorate undernutrition in early childhood, steps must be taken to ensure reliable delivery to households and to ensure household utilization behaviors. Often policy makers and program administrators assume that an intervention, such as a nutritional supplement, will seamlessly make its way along the road from delivery to utilization, particularly if the delivery system includes mechanisms to curb overt corruption that would prevent the substance from reaching its intended users. Evidence from evaluation research in public health, as well as nutrition, indicates that such assumptions are unwarranted. Even with the careful planning that was involved for the delivery of papilla within Oportunidades (Progresa) and the standard education program built into the cash and supplement transfer program, household utilization was inadequate. The results of this study show that utilization behaviors are amenable to change when caregivers are provided with the knowledge they need, and when the behaviors are compatible with their lifestyle and socio-cultural conditions.
A noteworthy feature of our study was the use of a randomized controlled trial design to test a behavior change intervention within the context of an ongoing program. The design permits the inference that an effect was due to intervention and not to extraneous factors. It demonstrates that, when programs and research organizations have the mandate and the social conditions to collaborate, identify, and address obstacles to delivery and utilization, research that meets the criteria for scientific rigor can be undertaken. Moreover, our study results indicated that improvements in household utilization of a nutritional supplement can be achieved with a communication intervention that is potentially feasible for implementation on a large scale. As a result of the study, expanded communication activities modeled on the intervention trial are being implemented on a larger scale within the Oportunidades Program. An effectiveness evaluation that includes an analysis of the costs of the communication activities can be undertaken when the behavior change component is taken to scale. Because the biological efficacy of the supplement to promote growth was previously demonstrated (5), this evaluation could also determine the magnitude of growth that results from adding the communication component to the program.
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ACKNOWLEDGMENTS |
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FOOTNOTES |
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Manuscript received 27 February 2006. Initial review completed 1 April 2006. Revision accepted 8 November 2006.
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LITERATURE CITED |
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TOPABSTRACTIntroductionMaterial and MethodsResultsDiscussionLITERATURE CITED |
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