Health coaching to promote healthier lifestyle among older people at moderate risk for cardiovascular diseases, diabetes and depression: a study protocol for a randomized controlled trial in Sweden

The aim of this study is to evaluate if repeated health coaching in terms of motivational Interviewing (MI) [9] will contribute to positive lifestyle modifications and health among persons aged 60–75 years, with moderately elevated risk for cardiovascular disease (CVD), diabetes, or mild depression. The specific aims are to estimate the impact of the intervention on the health-related quality of life (HRQoL), clinical parameters and measurements (especially blood pressure, HbA1c and waist circumference), self-reported lifestyle habits and whether the intervention is cost-effective.

Four county councils/regions with a total of 17 associated municipalities are included in the intervention. The intervention may be described as a partnership for healthy aging. The partnership refers to the local primary health care center (PHC) and the municipality as each of them is responsible for one part of the project: the PHC for the health coaching and the municipality for the organization and responsibility for local venues.

In addition, SNIPH and the non-profit sector each have their roles but share the same goal, to promote health and facilitate lifestyle modification from a holistic perspective.

SNIPH is responsible for management, education, and financial issues of the intervention. To increase the willingness of the county councils/regions to participate, the SNIPH allocated 15,000 SEK (1750 Euro) per participant in the intervention group and 3000 SEK (350 Euro) per participant in the control group, to cover all costs including intervention management costs.

Communication with the government and recruiting stakeholders started in 2010. The recruitment of four county councils/regions interested in preventive activities was finalized during spring 2011: they are Skåne, Jönköping, Sörmland and Värmland (Figure 1). These county councils/regions were selected from different parts of Sweden to include different socio-cultural living conditions.

In order to prepare for the intervention, SNIPH carried out educational activities in each county council/region, inviting personnel from both the PHCs and the venues. The goal was to gain a mutual understanding on concepts and methods used in the intervention, and on how active and healthy aging can be promoted. Main topics at the educational activities were inclusion criteria, measurements, the roles of different actors, learning more about MI and stimulating the development of venues and related activities.

In collaboration with the municipalities, the county councils/regions selected a total of 21 PHCs (Figure 1). In each county council/region, one project manager is responsible for the activities operated by the PHCs, and for carrying the collaborative work forward together with the municipalities. The selection of PHCs was made to represent both urban and rural areas as well as different socio-economic structures.

The PHC is responsible for recruiting health coaches with suitable educational qualifications and experiences, e.g. physiotherapists or community health nurses. Furthermore, the PHC is in charge of recruiting participants to the intervention. Methods for recruiting are advertising, information given at the PHCs, active outreach in public places, such as information to senior organizations, and letters of invitation to participate generated from patient records. The PHC is also responsible for initial screening, randomization to the control group or the intervention group, follow-up measurements and recording and storing data.

All participants have access to regular primary care. Participants in the intervention group are offered repeated health coaching sessions based on MI, including recommendation and motivation to participate in different physical, social and cultural activities. Persons developing high blood pressure or diabetes during the intervention period will be treated following available practices at each PHC. Test results are communicated to the participants in the intervention group during the MI session and to participants in the control group by the ordinary staff at the PHC.

The role of the health coaches is by MI, to motivate and support participants to modify their lifestyle. The completed questionnaires and the results from the measurements should be used as points of departure for the MI sessions.

The health coach and the participant meet at baseline and after 3, 6 and 12 months. In between these planned meetings, opportunities will be given for additional supporting conversations though extra meetings or telephone calls to increase the likelihood of lifestyle modifications.

In addition to MI, the participants will be offered and, depending on the individual motivation, encouraged to participate in activities available at venues operated by municipalities and non-profit organizations. Health coaches have enough knowledge about venues in the surrounding area to help participants find a suitable type of activity.

MI is an evidence-based approach built on cooperation between the interviewer and the individual. Individual motivation or resistance to events such as lifestyle changes plays a significant role in health and can be influenced by the interviewer's conversation strategies. The use of MI is growing rapidly, and there is strong evidence that MI is an effective treatment, especially with alcohol, tobacco and drug abuse but also in other behavioural changes. MI is more effective than traditional counselling, and MI effects are more prolonged and stable than other interventions ([10]). Furthermore, MI is regarded as cost-effective ([11]).

To ensure the quality of the interview technique, all health coaches were offered five MI conversations spread over 18 months and coded according to Motivational Interviewing Treatment Integrity Code 3.1. (MITI) [12]. The coaches sent in a tape of 20 minutes of MI conversation to Miclab [13], which conducted the coding. The MITI is a behavioural coding system which includes coding of twelve variables and estimates how well the MI is applied by the health coach. This method is used both as a treatment integrity measure of MI and to provide structured, formal feedback to the practitioner.

The municipalities are responsible for organizing venues. The venues should offer health promoting activities that meet the participant’s interests and need. A venue can either be operated by the municipalities or by non-profit organizations. Four factors are important to promote healthy aging (known as the ‘four cornerstones’); physical activity, healthy eating habits, social interaction/support and participation/meaningfulness/feeling. These four factors can affect health, especially for those who are still independent [14]. Hence, the requirements for venues are opportunities for physical activities, activities related to food and cooking, as well as cultural and social activities. The social activities should promote the creation of new relationships and fellowship among the participants and can vary depending on local conditions. One municipality has identified 43 venues, among which are found the city library, the art museum, yoga sessions, gyms, hydro-gymnastics, health lecturers and cooking courses. Another municipality, though, offers only three specific activities for participants.

Each municipality has a local coordinator who has the overall knowledge about the venues/activities offered by the municipalities as well as by non-profit organizations. The local coordinators are responsible for the development of venues and interaction with the stakeholders.

Non-profit organizations have no particular area of responsibility, but since they already run a range of physical and social activities, their involvement is considered necessary to meet the needs of the target population. Through collaboration with the municipalities, the non-profit sector´s expertise may be used to add resources in health promotion among the elderly.

The financial framework provided by the government allowed recruitment of 2000 participants, of which 1500 were assigned to the intervention group and 500 to the control group.

The target group comprises persons aged 60–75 years with early signs of hypertension, diabetes, obesity or mild depression. The following four inclusion criteria were applied:

Individuals with a worse result than inclusion criteria are treated according to regular guidelines at the PHCs and therefore not included. Exclusion criteria for the study are dementia, mental illness or other condition deemed unsuitable for participation.

The randomization procedure was done in two steps. First, each PHC centre received a list with code (ID) numbers where each number was assigned to either intervention or control group by using Excel software. By random assignment each included participant was given an ID number and allocated to the corresponding group. The total number of codes for each PHC differed, depending on the number of participants planned to recruit, but the distribution between intervention and control group were the same.

All participants fill out a questionnaire (Q1) at baseline, and at the 6-, 12- and 18-month follow-ups containing questions on demographic characteristics (only assessed at baseline), social life, HRQoL (EQ5D) [19, 20], lifestyle habits, general health/medication, self-rated mental health (MADRS) [16, 21], and sense of coherence (SOC-13) [22‐24] (Table 2).

At the 12-month follow-up, the health coach will give each participant a questionnaire (Q2) and a pre-paid return envelope addressed to the research group. The aim of Q2 is to capture attitudes and perceptions related to health coaching and venues/activities offered. The participants are instructed to fill out the questionnaire at home and send it by surface mail.

Qualitative data will be collected twice: at the beginning of the intervention and after the last MI at the 18-month follow-up. This is mainly to obtain a deeper understanding of perceptions and attitudes related to health and lifestyle/lifestyle modifications, as well as experiences of health coaching and venues. Focus group discussions will be held only in the intervention group.

One PHC in each county will be selected, guided by the pursuit of variation (urban/rural, high/low percentage of immigrants, women/men, etc.). Focus group discussions will be supplemented by a number of in-depth interviews. The study adheres to the RATS guidelines.

A health economic assessment will be performed. Costs for the intervention will be gathered from counties/regions and municipalities. Individual costs for health care utilisation will be collected from medical records and registers. QALY-scores are estimated for each individual based on their answers in the questionnaire and the cost per QALY gained will be estimated.

A prepared Excel document is delivered to every PHC. For each individual, a personal ID is created from the county ID, the PHC ID and a random individual ID. All ID numbers belong to either the control group or the intervention group. All data transferred from the PHC to the research group are anonymous.

The Excel document is organized to store one sheet for each period of data collection. Every cell in the document is prepared to minimize errors. Data collected at baseline are more comprehensive than the following as they contain background characteristics of the participants.

The possible effect of lifestyle changes will be estimated for participants fulfilling each of the four inclusion criteria. Thus, primary outcome variables are blood pressure, HbA1c, waist circumference and the MADRS scale [16, 21]. Effects on participants fulfillingq more than one criterion will also be analysed. Independently of inclusion criteria, the health-related quality of life will be followed over time using the instrument EQ-5D [19] as well as the clinical parameters triglycerides, HDL and LDL.

In addition, we will analyse some participant performance indicators related to the four cornerstones for healthy life [14]. These indicators are the validated SOC questionnaire [24], self-assessed frequency of physical activity, 6-minute walk test, and self-assessed frequency of eating habits.

The difference between measurements at baseline and at the 6-, 12- and 18-month follow-ups will be calculated, and the estimates in the intervention groups will be compared with the controls. Time trend analysis will be applied to test for a possible trend pattern.

EQ5D score is assumed to be 0,8 in the intervention group and 0,75 in the control group, and the standard deviation is assumed to be 0,3 in both groups. The intervention groups should be three times larger than the control group, power equal to 0,8 and alpha equal to 0,05. A two-side test requires thus 1132+377 = 1509.

Interviews and FGDs will be analysed using qualitative content analysis [27].

All participants are informed about the purpose of the study. Written informed consent is obtained and participants are ensured confidentiality. They are all informed about the possibility to end their participation whenever they want. All data are collected at each PHC and handled with secrecy. All participants are given a unique ID number which is sent together with data to the research group. The Regional Ethical Review Board in Umeå, Sweden, approved the study in August 2011, ref: Dnr 2011-230-31. The intervention is registered at the Current Controlled Trials web page (ISRCTN01396033).