Large Scale Implementation of MINISTOP 3.0

Karolinska Institute

Status: Active, not recruiting

Conditions: Obesity, Child

Treatments: Behavioral: MINISTOP 3.0

Study type: Interventional

Funder types: Other

Identifiers

NCT05667753

2022-01710-01

Details and patient eligibility

About

MINISTOP is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. MINISTOP has been previously been evaluated in two previous trials (MINISTOP 1.0 and 2.0) with promising results. Therefore, the overall aim of this trial is to evaluate the large scale implementation of MINISTOP within Swedish primary child healthcare. The specific aims are to:

(i) To compare two different implementation strategies for MINISTOP 3.0 (i.e., Basic vs.

Enhanced) on: a) acceptability, appropriateness, feasibility as well as organizational readiness to implement MINISTOP 3.0 within primary child healthcare (primary outcomes) and b) reach, costs, adoption, and sustainability of MINISTOP 3.0 within primary child healthcare (secondary outcomes).

(ii) To compare two different implementation strategies of MINISTOP 3.0 within primary child healthcare on children's key dietary indicators, physical activity, and screen time (secondary outcomes).

(iii) To compare the cost-effectiveness of two different implementation strategies for MINISTOP 3.0.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Child healthcare nurse at participating child healthcare centers

No exclusion criteria.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Basic

Active Comparator group

Description:

The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the basic group will receive the basic implementation strategy package.

Treatment:

Behavioral: MINISTOP 3.0

Enhanced

Experimental group

Description:

The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the enhanced group will receive the enhanced implementation strategy package.

Treatment:

Behavioral: MINISTOP 3.0