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Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes: The Sophia Step Study
Sophiahemmet University.ORCID iD: 0000-0003-4920-252x
Sophiahemmet University.ORCID iD: 0000-0003-4361-6502
Sophiahemmet University.ORCID iD: 0000-0002-4607-8677
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2021 (English)In: International Journal of Behavioral Nutrition and Physical Activity, ISSN 1479-5868, E-ISSN 1479-5868, Vol. 18, no 1, article id 121Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes.

METHODS: The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model.

RESULTS: In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group.

CONCLUSION: This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT02374788 . Registered 2 March 2015-Retrospectively registered.

Place, publisher, year, edition, pages
2021. Vol. 18, no 1, article id 121
Keywords [en]
Activity tracker, Behaviour, Cardiometabolic risk factors, HbA1c, Pedometer, Physical activity, Step counter
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:shh:diva-4214DOI: 10.1186/s12966-021-01193-wPubMedID: 34496859OAI: oai:DiVA.org:shh-4214DiVA, id: diva2:1604319
Available from: 2021-10-19 Created: 2021-10-19 Last updated: 2023-09-06Bibliographically approved
In thesis
1. Supporting healthy movement behaviours in people with metabolic risk, prediabetes, or type 2 diabetes in primary health care
Open this publication in new window or tab >>Supporting healthy movement behaviours in people with metabolic risk, prediabetes, or type 2 diabetes in primary health care
2023 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The overall aim of this thesis was to investigate if a pedometer-based intervention inthe primary health care setting can support people with prediabetes or type 2 diabetestowards healthier movement behaviours. Moreover, health care professionals’experiences of supporting people with metabolic risk factors to increase theirphysical activity were explored.

This thesis consists of four papers based on data from two research studies. Paper I,II, and III are based on a randomised controlled trial called the Sophia Step Study,which is a two-year, three-armed pedometer-based intervention. The three groupscomprised a multi-component group that received a pedometer and extracounselling, a single-component group that received a pedometer, and a controlgroup that received standard care.

The aim of the Sophia Step Study was to support individuals with prediabetes or type2 diabetes in becoming regularly physically active by reporting their daily number ofsteps, with or without extra counselling. Paper IV is based on a qualitative interviewstudy that explored nurses’, physicians’, and physiotherapists’ experiences in primaryhealth care when supporting patients with metabolic risk factors to physical activity.In paper I, the effects of self-monitoring steps with or without counselling supportfor HbA1c, other cardiometabolic risk factors and physical activity during the twoyearintervention were evaluated. In paper II, the effects of the intervention wereevaluated on relative time in different movement behaviours. In paper III, predictorsassociated with intermediate and post intervention increases in steps were explored. Finally, in paper IV, barriers and facilitators perceived by health care professionalswho work within Swedish primary care to support people with metabolic risk factorsto increase their physical activity were explored.

The results show that the Sophia Step Study did not have an effect on the primaryoutcome HbA1c. However, a significant effect was found for the multi-componentgroup on absolute time in moderate-to-vigorous physical activity during the entiretwo-year period, as well as for the single-component group at six months. No effect, however, was found for the absolute time in the other movement behaviours, thenumber of daily steps, any of the biomarkers or the anthropometric variables. Usingrelative time, instead of absolute time, when evaluating the effect showed a morepronounced effect in all movement behaviours within both intervention groups overthe two-year period. At six months, lower number of steps at baseline was asignificant predictor for increasing ≥500 steps per day. At 24 months, men, youngerparticipants, and those with higher self-efficacy at baseline had significantly higherodds for increasing ≥500 steps per day. Barriers and facilitators for supportingpeople with metabolic risk factors in increasing their physical activity, as experiencedby nurses, physiotherapists and physicians, were identified at multiple levels,represented by four generic categories: ‘Patient readiness for change’, ‘Supporting theprocess of change’, ‘The professional role’, and ‘The organisation of primary care’.

The overall conclusion is that the self-monitoring of steps with a pedometer seems tobe an effective behaviour change technique in maintaining healthy movementbehaviours; however, the counselling component of the intervention did not seem toimprove the effect. In addition, the intervention did not find evidence for improvedmetabolic control or improved cardiometabolic risk factors. Moreover, barriers toand facilitators for supporting patients with metabolic risk factors can be found atseveral levels within primary care, from individual patients and health careprofessionals to the organisational level. In the primary health care setting, thisshould be emphasised when implementing support with the intention to increasephysical activity in people with metabolic risk factors, prediabetes or type 2 diabetes.

Place, publisher, year, edition, pages
Stockholm: Sophiahemmet, 2023. p. 75
Series
Sophiahemmet University Dissertations ; 1
National Category
Nursing
Identifiers
urn:nbn:se:shh:diva-4995 (URN)978-91-988733-0-6 (ISBN)978-91-988733-1-3 (ISBN)
Public defence
2023-09-29, Weitnersalen, Sophiahemmet Högskola, Valhallavägen 91, hus R, Stockholm, 09:00 (Swedish)
Opponent
Supervisors
Available from: 2023-09-06 Created: 2023-09-06 Last updated: 2023-09-07Bibliographically approved

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Rossen, JennyLarsson, KristinaHagströmer, MariaJohansson, Unn-Britt

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