During year 1 (May 2009-Apr 2010), intervention programs and assessment plans were developed and focus groups were conducted. Focus groups determined which issues and problems relative to child obesity were of most concern to rural parents and assessed parents’ perceived needs for health information, their interest in program participation, and their time and availability constraints. At the close of year 1, final program design modifications were made, assessment instruments were obtained, assessment plans were finalized, plans for an 8-month pilot study involving parents in six rural Montana (MT) counties were completed, and recruiting of participants for the pilot study began. During year 2 (May 2010-Apr 2011), three of the six pilot counties received the 4-Health Educational program (experimental) and three received the Healthy Living Information program (control). The full implementation of experimental and control programs will begin in 21counties during year 3 (May 2011-Apr 2012). County agents who have a background in Family and Consumer Sciences (FCS) and 4-H (“Agents”) deliver the 4-Health Educational program during face-to-face meetings over an 8-month period between late September and late May. A Food and Nutrition Specialist and the 4-Health Project Director train Agents to deliver the program during one daylong session held in August. All phases of this project were reviewed and approved by the Montana State University Institutional Review Board for the Protection of Human Subjects, FWA 00000165.
The original proposal called for a two-group, delayed intervention control (waitlist) design with the experimental group receiving the 4-Health Educational program in year 2 and the waitlist group receiving the program in year 3. However, problems with this design became apparent during year 1. One problem was logistical. With the two-group delayed intervention design, Agents were expected to commit to two years of work during the summer preceding the beginning of the first intervention year. However, since Agents typically develop work plans annually, requiring them to commit to a 2-year project, severely limited the numbers willing to participate. An even more serious problem was the fact that a no-treatment (waitlist) control, although quite common in this type of research, would not adequately assess the effectiveness of 4-Health relative to existing prevention approaches. Consultants instead recommended that we use a “best-practices” control group (see below). Finally, as the 4-Health Educational program was being developed, it became clear that several new program activities and delivery methods would require pilot testing. Rather than only test a small portion of the intervention, we decided that a small pilot study was needed in which both the experimental and control programs could be delivered to small groups of participants.
The revised research design is a two-between-groups (experimental v. control) by two-within-groups (pre- v. post-assessment) design comparing the 4-Health Educational (experimental) program to a “best-practices” (control) program. Following additional discussion with consultants, the Healthy Living Information (control) program was devised, which provided participants with written information derived from USDA information sources (see below).
Semi-random cluster assignment
As an integrated research and outreach project, certain research design compromises had to be made. One compromise resulted from the regional diversity of the Montana population, which consists of a mix of rural and semi-urban counties. Only about half of the state’s population resides in predominantly rural or frontier counties. Since one purpose of the proposed project was to sample widely from these diverse rural populations, it was necessary to select counties for inclusion that were predominantly rural and as widely representative of the rural MT population as possible. A second compromise resulted from the method of participant recruitment. Extension Agents in each county are the point-of-contact between the 4-H Youth Development Programs and parents whose children participate in these programs. For this reason, it was necessary for Agents to have primary responsibility for recruiting qualified participants. However, before Agents could initiate recruiting, the project team felt it was necessary for them to have sufficient information about the treatment groups to inform parents, in general terms, about the nature and extent of their commitment. Furthermore, while some Agents were willing to be randomly assigned to treatment groups, others preferred assignment to only one of these groups.
As a result of these constraints, the research design consists of a semi-random cluster design in which Agents (representing groups of 4-H parents) are first recruited from Eastern and Western regions of the state and their preferences for delivering either the experimental or control program are determined. Agents are then assigned to treatment conditions based on their preference and their geographic location, such that pairs of adjacent counties, with similar participant demographics, are assigned to each treatment condition (Figure ). This assignment strategy represents a type of regional matching of experimental and control counties. Once assigned to treatment groups, Agents recruit participants within the 4-H clubs in their county or an adjacent county with the aim of recruiting 7–10 parent–child dyads who meet participation criteria. All recruiting materials refer only to the treatment conditions appropriate to the Agent’s group assignment and Agents are asked not to disclose the existence of treatment conditions other than the one for which they are recruiting.
Participant recruitment, assignment, and data collection flow chart.
Marketing and participant recruitment
Agents in rural and frontier MT counties were initially notified of the forthcoming 4-Health Program at the MSU Annual Extension Conference (fall 2010) and tentative interest in participation was subsequently determined. A total of 25 agents representing 30 MT counties expressed an interest and indicated their preference for either the experimental or control groups or their willingness to be assigned. Subsequently, Agents were contacted to determine whether they would be able to recruit a sufficient number of qualified participants. Of the 25 who expressed interest, 21 ultimately agreed to participate. In five cases Agents located in one county agreed to recruit participants from adjacent counties, such that a total of 26 of the 56 MT counties are represented. During a full-day training session Agents received an orientation to the project, learned about marketing, recruitment, and program logistics, reviewed the Parent and Facilitator Guides, and participated in sample program sessions.
Parent recruitment materials describing either the experimental or control programs were provided to all Agents hosting a group in their county. Agents strategically placed recruitment posters and program information in locations frequented by parents of 4-H youth and sent out recruitment materials to 4-H parents in their county. Additional methods used to reach parents were announcements and information at county fairs, announcements in 4-H newsletters, electronic and/or printed announcements to 4-H clubs, emails to 4-H listservs, and phone calls to 4-H leaders. To be eligible for participation parents were required to enroll one child aged 8–12
years old and both parent and child agreed to participate in assessment sessions immediately before and after the 8-month intervention and at 6-month follow-up. Parents selected to participate in the 4-Health Educational (experimental) program also agreed to attend 10 x 90
min face-to-face meetings at or near their County Extension Office. Those parents and children selected for the Healthy Living Information (control) group agreed to attend the pre, post, and follow-up assessment sessions but were only expected to receive and read the printed Healthy Living Information program materials, mailed to their homes in monthly installments over eight months (September – April). Written informed consent for participation in the study was obtained from each parent, who also provided consent for his or her child. Children signed a separate assent form.
Standard deviation estimates were based on a pilot study consisting of 23 experimental and 16 control participants. Assuming a final participant pool of 75 per group for the current study, with an alpha of .05, and within-groups standard deviation estimates based on the pilot study, power was calculated for two primary outcome variables, BMI z-score change (pre- vs. post-intervention) for children and BMI change for parents. For the first calculation, we assumed a between-groups difference in BMIz for children of 0.15 and a within-groups standard deviation estimate of 0.24. For the second calculation, we assumed a BMI difference of 0.60 and a within-groups standard deviation of 1.18. With 75 participants per group, the estimated power for the child BMIz was 0.96 and the estimated power for the parent BMI was 0.87.
4-Health educational (experimental) program development and delivery
Two interventions were developed for this research project, an active intervention (4-Health Educational Program) for use with the experimental group and a “best-practices” (Healthy Living Information) intervention for the control group, described below. Extension specialists from the research team utilized current research, focus group results, and selected components from existing research-based curricula to develop a pilot version of the 4-Health Educational Program curriculum. Steps-to-a-New-You [20
] served as the initial curriculum foundation establishing basic health topics including food and nutrition, physical activity, and positive body image. STEPS is part of an on-going program offered through Montana State University Extension, which embodies HAES principles including: valuing health, respecting body-size differences, enjoying the benefits of self-acceptance, enjoying physically active living, and enjoying healthful and pleasurable eating. In addition to the basic health topics, a parenting component was added, which recognized the importance of the child’s psychological and behavioral goals, mutual respect between parent and child, and appropriate parental encouragement via positive reinforcement. This component also emphasizes effective communication, such as listening and responding to the child’s feelings, rather than lecturing and criticizing, resulting in more effective parent–child interaction. Parents are taught how to motivate and help support their children, thereby encouraging positive changes in behavior. This parenting component draws heavily from the Food-Related Intergenerational Discussion Group Experiences (FRIDGE) curriculum, a family-centered program based on a grounded theory approach and designed to improve family communication and decision-making in relation to nutrition [21
]. Finally, the 4-Health Educational curriculum incorporated components of Essential Elements for Positive Youth Development
], a curriculum for adults which draws on the developmental theory of Lerner et al. [23
], emphasizing the need to align youth needs with available environmental assets.
Thus, the 4-Health Educational program includes the topics, objectives, and activities outlined in Table . Food and Nutrition: choose foods and beverages packed with nutrients; increase fruits and vegetables, low-fat dairy foods and beverages, and whole grain choices; decrease sweetened beverage consumption; eat meals and snacks regularly; choose food portions appropriate for activity level; increase times when families eat together; practice the principles of normal, healthy eating; avoid unhealthy weight-control practices. Physical Activity: create an accessible physical environment that promotes an active lifestyle; reduce sedentary time; promote physical activity via whole-family communication; take advantage of available community sites for physical activity. Positive Body Image: encourage size and body acceptance of self and others; understand media and environmental influences on the development of body image; teach and model healthy self-esteem, respect, and confidence. Parenting: practice good communication skills; provide high levels of love, warmth, and boundaries; advocate for preteen child; provide opportunities for preteen child to grow and develop his or her own identity.
4-Health Educational Program Sessions
Facilitator guides include all 4-Health lessons plans, agendas, scripted PowerPoint presentations, handouts, a resource list, participant and facilitator evaluations, and take-home activities, which establish and apply skills for lifestyle behavior changes for youth and parents. Each lesson includes one or two objectives that cover health topics (food and nutrition, physical activity, body image), but also integrates objectives that introduce social-cognitive strategies, such as SMART Planning [24
], a goal setting method that helps users identify what they want to accomplish and assists them in creating a plan to reach their goals related to each health topic. A website developed for the general public, with a protected user-only section, allows forum discussions among participants.
Healthy living information (control) program
The Healthy Living Information program consisted of written information based on the USDA’s ChooseMyPlate [25
] website and the American Dietetic Association’s [26
] internet resources. Approximately every three weeks between late September 2011 and April 2012, corresponding approximately to the meeting times for the 4-Health Educational program, participants in the control group receive mailed packets of information. Table is a list of the packets and topics of the materials sent in each of 10 mailings.
Healthy Living Information Program Packets and Topics
Assessment topics and procedures
Before beginning of the program, parent participants and one of their 8–12
year old children attend the pre-program assessment session. At this session, weight, height, blood pressure, and heart rate are taken from each parent and child. Parents and children also complete separate survey packets (see below). All participants complete identical assessments again after completing the intervention programs and at a 6-month follow-up. All assessments are carried out with groups of participants at county Extension offices (or nearby locations). Specific assessment times generally occur during the three weeks preceding (pre) or following (post) program delivery and within two weeks of the 6-month follow-up period. Teams of data collectors (3–4 members per team), hired and trained for each data collection period, travel to each county data collection site at designated times. Data collectors receive two days of intense training on the research protocol, use of equipment, and how to interact with the program participants so that data collection will be highly consistent and sensitive to participants.
Participants in both the experimental and control groups receive $50 for completing each assessment session. Participants who complete the study also receive a $200 stipend. In order to receive the program stipend, participants in the 4-Health Educational Program (experimental) group are required to attend at least eight out of the 10 face-to-face sessions. Experimental program participants also receive a small travel stipend depending on the distance traveled to and from sessions and the number of sessions attended.
The following measures are obtained both from parent and child: height, weight, resting heart rate, and resting systolic and diastolic blood pressure. Height is measured in centimeters two times using a Seca 217 stadiometer and weight is measured in pounds, using a Tanita WB-110A scale, both procedures following the National Health and Nutrition Examination Survey (NHANES) protocol [27
]. Three independent measurements are taken for resting heart rate and resting blood pressure, with one minute of quiet rest between each measurement, using an automated Omron HEM-705-CP monitor and following the Omron manual protocol.
Children complete the following questionnaires concerning their attitudes and behaviors related to physical activity, food and nutrition, body image, appearance, body esteem, self-esteem, and quality of life.
Physical activity/healthy foods efficacy scale for children
Self-assessment of goal setting for physical activity and healthy food choices and self-efficacy for physical activity and healthy food choices [28
Physical activity questionnaire for older children
Self-report of physical activity in children 8–14
years of age [29
Youth risk behavior survey
Self-assessment of health-risk behaviors among youth. We include only the items concerning physical activity and unhealthy dietary behaviors [30
Coordinated approach to child health-health behavior questionnaire, section D
Self-assessment of behavior and psychosocial variables related to nutrition and physical activity [31
]. We include only items about children choosing and fixing their own snacks and meals.
Self-assessment of priority, atmosphere, and structure/rules at family meals [32
Child body image scale
Self-assessment of body size perception and body size dissatisfaction [33
]. Seven gender-specific body shape figures are presented representing standard percentile BMI differences for healthy children. Children are asked to: “identify the body figure most like your own” and “identify the body figure you would most like to have.” Body size perception is calculated as the difference between the BMIz representing the shape selected as ‘most like your own’
and the child’s actual
BMIz. Body size dissatisfaction is calculated as the difference between the BMIz representing the shape selected as ‘would most like to have’
and the child’s perceived
Body Esteem Scale (BES)
Self-evaluation of own body and appearance [34
]. The BES has three subscales: BE-Appearance (general feelings about appearance), BE-Weight (weight satisfaction), and BE-Attribution (evaluations attributed to others about one’s body and appearance).
Socio-cultural attitudes toward appearance questionnaire
Measures endorsement of societal appearance ideals [35
Coopersmith self-esteem inventory
Assesses attitudes toward self in personal, social, family, and academic areas of experience [36
Self-assessment of child’s quality of life, including physical well-being, psychological well-being, parent relations and autonomy, social support and peers, and school environment [37
Parents complete the following questionnaires concerning their attitudes and behaviors related to physical activity, food and nutrition, body image, personal appearance, parenting style, family communication, making healthy choices for their family, and various demographic characteristics.
Exercise self-efficacy scale
Assesses self-efficacy expectations related to the ability to continue exercising in the face of barriers [38
Assesses leisure time physical activity [39
]. We add questions about additional activity throughout the day.
Health-promoting lifestyles profile II
Evaluates various dimensions of health-promoting lifestyle [40
]. We include only items defining three of the dimensions: nutrition, physical activity, and stress management.
Child feeding questionnaire
Self-assessment of parental beliefs, attitudes, and practices regarding child feeding, including perceived responsibility for child feeding, parent perceived weight, perceived child weight, parents’ concerns about child weight, monitoring of child’s food intake, and restriction of child’s food intake and pressure to eat [41
Same as child questionnaire (see above).
NHANES flexible consumer behavior module, 2009–2010
Includes selected items concerning overall diet quality, frequency of eating away from home, and frequency of eating at fast food restaurants [42
NHANES consumer behavior family questionnaire, 2009–2010
Includes selected items concerning availability in the home of the following foods: fruit, dark green vegetables, salty snacks, skim milk, and soft drinks [43
Appearance schemas inventory-revised
Consists of two subscales in relation to one’s cognitive-behavioral investment in appearance. Self-evaluative salience assesses the extent to which individuals define or measure themselves and their self-worth by their physical appearance, which they deem influential in their social and emotional experiences. Motivational salience assesses to the extent to which persons attend to their appearance and engage in appearance-management behaviors [44
Parenting style and dimensions questionnaire
Three-factor self-assessment of parenting style. Authoritative parenting style items evaluate parent–child warmth and connection, parental use of reasoning, inductive parenting, and autonomy granting. Authoritarian parenting style items evaluate physical coercion, verbal hostility, and non-reasoning/punitive disciplinary practices. Permissive parenting style items evaluate parental indulgence and inconsistency [45
Family communication scale
Self-assessment of positive aspects of family communication, focusing on a free flowing exchange of information both factual and emotional. Assesses the degree to which family members feel unconstrained and satisfied with the communication within their family [46
Healthy choices self-efficacy
Assesses parental confidence in making overweight-related behavior changes for their family [47
Items include race/ethnicity of parent and child, marital status, employment, education, income, and distance from home to the nearest convenience grocery store, the nearest full service grocery store, and the child’s school.
Parent evaluation of child
Parents complete the following questionnaires on obesity related topics as they relate to their child including the child’s sedentary behavior, food intake, and quality of life.
Sedentary behavior questionnaire
Assesses a broad range of sedentary activities common among adolescents [48
Fred Hutchison cancer research center food frequency questionnaire
Quantitative assessment of child’s nutrient intake. Detailed nutritional analysis of the child’s diet is derived by standardized procedures developed by the Nutrition Assessment Shared Resource [49
Same as child questionnaire (above) but completed by the parent as the child’s proxy.
Parents provide information on the child’s usual week
day and weekend sleep and wake times, frequency of family dinner consumption, and frequency of the child’s breakfast eating.