Acceptability of delivery modes for lifestyle advice in a large scale randomised controlled obesity prevention trial

HeLP-her Rural program design and theory

The Healthy Lifestyle Program (HeLP-her Rural program) is an integrated community
cluster randomised controlled trial (RCT) designed to prevent weight gain in a population
of reproductive-aged women living in rural Victorian communities in Australia. Detailed
study design methodology are comprehensively explained elsewhere 22]. In summary, the program was designed to be low intensity and focused on participants
making small long-term sustainable behaviour changes. In this program 41 rural communities
were randomised to intervention or control groups. The control participants attended
a single general group health information session. The intervention participants received
lifestyle advice through mixed delivery modes including (i) limited personal contact:
one group session and (ii) remotely, consisting of: one phone coaching session, monthly
text message reminders and a program manual. The intervention content was based on
the principles of building self-management informed by the self-determination theory
23] and motivational interviewing 24]. The primary outcome was the difference in weight gain between the control and intervention
groups at 12-months.

Sample size calculations

The sample size calculations were completed a-priori as outlined in the published
protocol 22] and clinical trial registry. In the calculation of sample sizes for the primary outcome
(weight change over 12-months), adjustments were made for the clustered design prior
to program recruitment. The variance inflation factor (VIF) used to achieve this was
determined from the average cluster size and the Intra-Cluster Correlation (ICC).
The trial was powered to detect a difference of 1.0 kg in weight between groups at
12 months, the weight difference achieved in our original trial (HeLP-her) 25] and the estimated population weight gain 3]. The actual ICC calculated in the previous HeLP-her study was ?0.02 using Generalised
Estimating Equations, (GEE) 26], despite the negative value is assumed to be equivalent to zero. However we assumed
some clustering in this setting although likely small and notably there was little
published data to inform the ICC estimates in rural communities. Therefore, to detect
an absolute difference in weight between groups, 196 women per intervention arm (control
and intervention) were required to participate in the HeLP-her Rural program. Adjusting
for the cluster design with a variance inflation factor (VIF) =1.28, cluster size
of 15, and allowing for 20 % attrition over 1-year, we aimed to recruit a minimum
of 600 women into 40 clusters of 15 women. To allow for inadvertent recruitment challenges
42 towns (clusters) were randomized.

HeLP-her rural program recruitment

Participant recruitment commenced in September 2012 and was completed in April 2013
(Fig. 1). Program recruitment was underpinned by a comprehensive community communication
and engagement plan 22]. Participant recruitment strategies were intentionally simple and low cost to reflect
usual practice and centred on community integration within current structures. Participants
were recruited through the distribution of an invitation letter and flyer to women,
provided through primary schools, pre-schools, child care centres and health services
in each township. All women aged 18–50 living within each of the 41 selected townships
were invited to participate and to assist program recruitment research staff visited
each township to provide information in person to participants.

Fig. 1. Consort Diagram

HeLP-her Rural program delivery and implementation

Multiple intervention components were utilised based on existing evidence of efficacy
and feasibility 25], 27], 28]. The delivery modes were designed to reinforce program messages, appeal to various
learning styles and preferences and to maximise cost-effectiveness via delivering
lifestyle advice remotely, whilst retaining some personal contact. The group education
session provided an opportunity to receive personal contact, improve social support
amongst participants and encouraged participants to set appropriate health goals based
on personalised priorities. During this group session five simple healthy lifestyle
messages related to weight gain prevention were presented by the program facilitator
(e.g. try to eat 2 serves of fruit and 5 serves of vegetables per day, reduce soft
drink intake and take a brisk walk for at least 30 min on most days of the week).
Education was provided on building behavioural self-management capacity including:
goal setting, action planning, addressing barriers, problem solving and relapse prevention
skills. For example rather than advising women to eliminte takeaway food we focused
on how they could prepare a healthy meal for the family, despite their multiple family
and women commitments. At the end of the group education session participants had
generated lifestyle goals and action plans based on their personal priorities and
therefore had developed a personalised weight gain prevention strategy.

The program manual was incorporated to promote participants to self-manage their health
behaviours though the completion of self-directed activities. Participant were required
to document their health goals within their program manual. The phone coaching utilised
client orientated counselling approaches and promoted behaviour change through exploring
and resolving ambivalence 29]. Women unable to complete the phone coaching were mailed a summary sheet of the core
messages provided. The text messages reinforced the program content and accountability
30]. The primary outcome of HeLP-her Rural program was the difference in weight gain
between the control and intervention communities at 12 months post program initiation.

HeLP-her Rural process evaluation design and theory

The evaluation ran parallel to the HeLP-her Rural program which monitored, documented
and assessed program implementation processes 16], 31]. Specific dimensions of the process evaluation measured were; program fidelity, recruitment
strategies, dose of the program delivered, program acceptability and contextual factors
influencing program implementation. A logic model was developed to monitor the program
evaluation, reflecting resources and activities (inputs), and underlying theory and
anticipated program outcomes.

The intervention study and the evaluation were approved by the Monash Health Research
Ethics Committee for research involving humans, project No.12034B.

Evaluation data collection methods

The evaluation utilised a mixed method data collection approach, recognising the synergistic
benefits of both qualitative and quantitative research methods. Methodologies included
qualitative semi-structured interviews with a sub-group of intervention participants
and quantitative methods (program specific checklists and questionnaires) (Table 1).

Table 1. Summary of the HeLP-her Rural program methodology and data collection time points

Table 2. Quantitative results on different delivery modes at 12 months

Four types of process evaluation data were collected here utilising qualitative and
quantitative methods. This is comprehensive for this type of program evaluation. Data
collection methods used included: 1) administration data, 2) checklists and observations
completed by the research team, 3a) surveys and questionnaires completed by participants
and 3b) qualitative semi-structured interviews 18].

Administrative data and contextual data

To explore program reach and context, data from the Australian Bureau of Statistics
(ABS) measuring Socio-Economic Indexes for Areas (SEIFA) of relative disadvantage
was used. Potential scores ranged from 1–10 with a lower score indicating a greater
level of social disadvantage relating to household total income, education attained
and unemployment rates 32]. We categorised scores into four groups: SEIFA score 1–2, SEIFA score 3–4, SEIFA
score 5–6 and SEIFA score 7. To determine the relationship between SEIFA indexes
and the number of program participants recruited from each township, statistical data
analysis was performed in consultation with a biostatistician using SPSS version 19.0
for Window 33]. A two-sided value of 0.05 was considered statistically significant. Comparisons
between sub-groups were explored using a one-way ANOVA and post-hoc Scheffe test with
SEIFA index the between-subject factor.

Building on this, we explored the relationship between participant’s perceptions of
the supportiveness of their environment and SEIFA index of their township. Participant’s
perceptions of the supportiveness of their environment measured via a baseline questionnaire,
“do you believe your local area takes an active role in promoting healthy lifestyle
to women”. Exploration of the relationship between participant’s environment and SEIFA
scores were tested using chi-square (categorical data).

Program checklists and staff observations

Devised program specific evaluation checklists, research team field notes and staff
observations were utilised to evaluate program fidelity, dose delivered and program
context. Program checklists were informed by previous literature and pilot tested
and modified during the early phases of implementation 34]–36]. The checklists documented recruitment strategies used, the time taken to deliver
the program sessions, the program activities completed, number of people completing
all activities, participant engagement and barriers and enablers to delivering health
information. The checklists further included a set of core intervention components
that needed to be delivered by the program facilitator during the group education
session and phone coaching.

This program was delivered by research staff (health professionals) working in pairs;
with one staff member facilitating the group education sessions, with the other observing
and recording their observations. The staff member observing the delivery of the group
education session provided feedback to the program facilitator, ensuring consistency
of program delivery across all communities. Fidelity was addressed by all staff undergoing
a one day training workshop, receiving on-going support and the use of standard delivery
resources. During training staff were advised of the core elements to be delivered
and where they could adapt the program to their local audience.

Interviews, surveys and questionnaires completed by participants

Surveys and questionnaires: quantitative data

All program participants (control and intervention) were invited to complete validated
and devised questionnaires at baseline and 12-months post program enrolment. Questionnaires
included items on demographic characteristics, socio-cultural and physical environment,
health status (psychological and physical), food intake and physical activity. To
assess program satisfaction and acceptability participants completed a program devised
satisfaction survey and ranked each intervention component (group session, text, phone
coaching and program manual) on a likert scale (1–5), where 1?=?not at all helpful
to 5?=?extremely helpful. To see if there were differences in satisfaction scores
across the various program components paired T-tests were conducted. A two-sided value
of 0.05 was considered statistically significant. Data was analysed using SPSS version
19.0 for Window 33] with results presented as means and frequencies.

Qualitative semi-structured interview sampling, methods and analysis

The acceptability of each program component was assessed through qualitative semi-structured
interviews conducted in a sub-group of intervention participants only at six months
post intervention commencement. A criteria-based, purposive sampling approach was
performed regarding the following criteria; 1) towns allocated to receive the intervention
only, 2) local government region (equal representation across all five local government
regions involved) and 3) town population size (2000–7500). Twelve towns were eligible
for participation in the qualitative sub-study and six were randomly selected for
participation. All participants from the six selected communities were invited to
participate in the semi-structured interviews.

Exclusion criteria for the semi-structured interviews

Participants who did not receive the full intended dose of HeLP-her Rural program
(initial group session X 1, phone coaching session X 1 and received both the program
manual and SMS text messages) were not eligible for participation in the semi-structured
interviews. This was because the focus of the semi-structured interviews was to determine
the acceptability of the various HeLP-her Rural program components. Subsequently,
control participants were also excluded as they did not receive the various intervention
components.

Semi-structured interview conduct

All participants were provided with information regarding their involvement in the
qualitative semi-structured interviews, prior to participation. Written consent was
provided by all participants and a letter and follow–up phone call sent to consenting
volunteers. To ensure consistency between all interviews a single researcher conducted
all interviews guided by a developed interview guide (Additional file 1). The interview guide focused on 5 broad topics; 1) Motivation for program attendance
and program expectations, 2) Impact of the HeLP-her Rural program on the broader community,
3) Behaviours change achieved, 4) Exploration of program engagement and utilisation
of the various program components and 5) program satisfaction. The interview questions
were pilot tested and reworked throughout the interviews allowing for exploration
of new ideas and themes. In this manuscript, the qualitative data presented focused
primarily on program satisfaction with other qualitative findings to be published
elsewhere. This manuscript also reports on quantitative data relating to program fidelity,
recruitment, retention and dose delivered.

Those who agreed to participate were interviewed by phone for 25–50 min. Interviews
were conducted until data saturation, determined when no new ideas emerged from the
interviews, as per standard methods 37]. All qualitative semi-structured interviews were audio-taped and transcribed verbatim.
De-identified transcripts were thematically analysed independently by two investigators.
Analysis was conducted prior to knowing whether the intervention had been effective
at preventing weight gain. In depth discussions of emerging themes took place before
a final iteration of the results was agreed upon between investigators. An independent
qualitative researcher was included to counteract the dual role of the researcher
delivering and evaluating the program.