Breast Cancer Clinical Trial
Official title:
Healthy Families: a Cluster Randomized Study to Change Obesity in Public Housing
This is a cluster randomized study of an environmental level intervention to improve nutrition and physical activity, among public housing residents. Followup was one year post baseline
Purpose and design The purpose of this study was to test the effects of a
environmental-level package of interventions on public housing residents' obesity and
obesity-related behaviors. The design of the study and its intervention have been previously
published . Simply, this was a cluster randomized trial, with public housing developments
(PHDs) serving as the unit of randomization and analysis. This document describes the
patterns of change in the main behavioral and weight outcomes for adult women before and
after the intervention.
Participants Public housing in Boston is administered by the Boston Housing Authority (BHA),
a public agency that provides subsidized housing to low- and moderate-income individuals and
families, disabled individuals, and elderly individuals. There are 64 public housing
developments, 37 are designated as elderly/disabled developments and 27 are designated as
family developments. Approximately 27,000 people are housed under the public housing
program.
Family (vs. elderly) designated PHDs with more than 200 residents which were not undergoing
renovations requiring residents to move out of the development for a period of time in the
City of Boston were eligible to participate in this study (n=24). The investigators
recruited 10 developments to participate in the Healthy Families study; 5 serving as
intervention PHDs and 5 serving as control PHDs. PHDs were randomly assigned to either
condition, in matched pairs for size of development and existence of health activities in
the development. PHDs randomized to the intervention group received all intervention
components (see Intervention section below) and developments randomized to the control group
did not receive any intervention components.
Data collection In both intervention and control group PHDs, a randomly sampled group of
female residents and their daughters ages 8-16 were recruited into an evaluation cohort to
examine study outcomes. The investigators selected mothers because in the family
developments over 80% of heads of household (per aggregate data compiled from tenant
agreements) were women. The investigators selected daughters aged 8-15 as development of
obesity often occurs during this time period for females. To be eligible for this study,
participants were required to be female, age 18-72, live in one of the recruited PHD, and
planning to remain so for two years, had responsibility for a girl age 8-15 (also living in
the public housing residence), were English or Spanish speaking, and were able to make
changes to their diet and physical activity habits if desired. Exclusion criteria included:
the adult was not able to complete the survey tools or was not interested in participating.
All study materials were available and used in both English and Spanish.
Survey assistants approached randomly selected apartment units within each of the 10 housing
developments. Using a standardized protocol, survey assistants assessed individual's
interest in participating and eligibility. If interested and eligible, the participant
provided their written informed consent to participate, girls aged 12-15 provided written
assent, and girls aged 8-11 gave verbal assent. The survey assistant then administered the
baseline survey and recorded the (adult) participant's responses. After completing the
survey, the women and girl's height and weight were measured and recorded. Project staff
returned to re-assess the original evaluation cohort at one- year follow-up.
Measures Baseline survey. Dietary intake is difficult and time consuming to measure, and so
in the interest of minimizing participant burden we decided to measure key single behaviors
related to obesity for which there were existing measures. Following evidenced-based
guidelines for health promotion and weight management, we assessed three nutrition
behaviors: fruits and vegetables ("How many servings of fruits and vegetables do you eat
each day?" with 12 responses ranging from 0 to 11 or more, which was prefaced with pictures
representing portion sizes); soda ("How often do you drink soft drinks or soda pop (regular
or diet)?" with 6 responses ranging from never to 2 or more times per day); mindless eating
("How often do you eat food (meals or snacks) while doing another activity, for example,
watching TV, working at a computer, reading, driving, playing video games?" with 5 responses
ranging from never to always). The same measurement difficulties exist for physical
activity, and so investigators used the same strategy to select key single items that have
been used before in research studies and compared well with longer measures. We assessed
physical activity in the form of walking for leisure, transport, or exercise during the past
week with the following question: "During the last 7 days, on how many days did you walk for
at least 10 minutes at a time in your neighborhood?" with responses ranging from no walking
for more than 10 minutes at a time or the option to fill in number of days per week and
number of minutes per day. Number of days/week was multiplied by minutes/day to calculate
minutes of walking per week. To assess walking on a typical day, we then asked: "On a
typical day how many minutes do you walk in your neighborhood?" with the option to fill in
minutes per day. Finally, the survey assistant measured the height and weight of both the
mother and daughter using a scale. This was used to calculate body mass index (BMI, kg/m2).
Both body weight and survey variables were planned to occur annually for the duration of the
study.
Participants completed standard questions about socio-demographics (e.g., age,
race/ethnicity, highest level of education completed, self-rated health), psychosocial, and
behavioral variables. To assess self-efficacy to eat more healthfully, surveys asked "On a
scale of 0 to 10, how sure are you that you will eat less sugar and fat during the next
year?" with 11 responses ranging from 0 (not sure) to 10 (very sure).
Intervention The Healthy Families intervention was developed using the conceptual model
depicting the mother-daughter pairs who are at the center of our intervention surrounded by
three main environmental-level categories of influence: community, organizational, and
consumer nutrition and physical activity environments. The main emphasis of the model is on
various environmental influences, with individual-level factors, socio-demographics and
psychosocial factors, influencing eating and physical activity patterns. Healthy Families
contained multiple intervention components: lay health advisors, health screenings, walking
groups, nutrition and cooking demonstrations, healthy purchasing options, and neighborhood
resource maps. Investigators chose these components to comprise our intervention since they
could be implemented within a short period of time, could be sustained by the developments
at the conclusion of our project, and were built on research already conducted by the
Partners in Health and Housing=Prevention Research Center.
Lay Health Advisors. The intervention components were coordinated by residents of public
housing who had completed a 14-week training in community health outreach, a long-standing
program (12+ years) provided by the PHH-PRC. Upon completion, these lay health advisors
complete a six month paid internship in their public housing development, distributing
health information on a variety of topics of concern to residents and helping to link
residents to neighborhood health- and clinical-related resources. From the pool of
approximately 100 lay health advisors, a subset was selected to be trained in
obesity-specific knowledge and procedures to serve in the Healthy Families intervention.
They completed an additional 3-day training covering research processes (e.g., protecting
participant privacy), study-specific protocols, and obesity management (e.g., health
implications of obesity, effective approaches to supporting weight loss) and passed a
post-training assessment to demonstrate their knowledge. Upon completion, these trained
residents, called Healthy Living Advocates (HLAs) (n=5), served to coordinate the Healthy
Family activities, described below, in the 5 intervention developments.
Health screenings. Screening for risk factors for chronic disease is one of the most widely
used strategies to prevent mortality and morbidity for chronic disease in modern
industrialized countries. Identification of risk factors, measured in blood or other body
fluids, or by body function, like blood pressure, offers information about a person's
overall risk for development of chronic diseases, like cardiovascular disease and diabetes.
Among public housing residents, we found in previous work that both rates of participation
in screenings and the rates of positive screens for chronic disease was high among residents
when the screenings were held inside the housing developments. Therefore, the study offered
monthly screenings for blood pressure, smoking, and diabetes risk for individuals to learn
about their chronic disease risk and be referred to a program within the Healthy Families
intervention, to their own provider, or given information about how to obtain a provider if
they did not have one. Due to expanded public insurance options, 94-97% of non-elderly
adults in Massachusetts had health insurance at the time of this project, removing this
classic barrier to care. The screenings were 3-4 hours in duration, held in a shared space
in the development, were advertised for 2 weeks prior, and were administered by research
study staff. HLAs attended all screenings to assist with linking residents to the primary
care system as needed.
Access to healthy food. Increasing access to healthy foods is a key component of improving
the food environment, yet, adding supermarkets or changing the existing store resources
(e.g., adding refrigerated units to accommodate fruits and vegetables) can takes years to
perform and are often expensive. Additional options, such as farmer's markets and urban
gardening, can be limited by their seasonal nature and may have differential patterns of use
in different areas of the U.S. To provide immediate, affordable, and easy access to healthy
choices, we selected providing access in the form of a van (Fresh Truck) that sold fruits
and vegetables to residents of public housing. The van visited each intervention housing
development weekly. HLAs at each development promoted the van's offerings and were present
while the Fresh Truck was parked on-site.
Walking groups. Research suggests that the built environment is a powerful influence on
behaviors. Significant environmental barriers to walking, particularly among multi-cultural
low-income women, have been well-documented and include lack of sense of safety and lack of
places to exercise. Pilot work indicates that walking groups are well-accepted by public
housing residents, with about 20% of residents participating across 4 housing complexes,
reporting self-reported increases in days of walking and social cohesion. Walking groups
were held weekly, with HLAs serving as walk group leaders and promoting the groups in the
developments via flyers and word of mouth.
Cooking demonstration. Numerous successful multi-component interventions with the aim of
reducing overweight and obesity have used cooking demonstrations as part of their
programming. These cooking demonstrations offered residents the opportunity to obtain
nutrition education as well as to shape social norms around healthful food practices among
friends/family/neighbors. A common theme of our cooking demonstrations was tailoring recipes
to fit the targeted cultural context. Prior to the Healthy Families project, nearly all
residents and management at targeted developments reported a desire to bring cooking classes
to their neighborhoods as they were thought of as family-friendly activities and positive
social functions in which neighbors could get together and work towards a common goal. The
cooking demonstrations were held four times per development, led by a Registered Dietitian,
and promoted beforehand by the HLAs using flyers and word of mouth, as well as via social
media. The dietitian compiled a number of culturally diverse recipes which included foods
that were available for purchase from the Fresh Food Truck and were SNAP eligible and WIC
approved. At each demonstration, the dietitian prepared two recipes and provided nutrition
education on a number of topics such as whole grains and sodium reduction.
Resource maps. Maps listing local health related resources (such as local gyms, walking
parks, and healthy buying and eating establishments) were made available to development
leaders and to all interested participants at health screenings, food van session, walking
groups, and cooking demonstrations.
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