Assessing the effectiveness of the Greenhabit method (mHealth) for lifestyle modification in diabetes

The efficacy of the Greenhabit method (mHealth) for lifestyle modification in diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13456652

Enrollment

120

Registered

2021-05-22

Start date

2021-09-06

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving health and preventing the appearance of possible complications associated with diabetes through changes in lifestyle and dietary pattern Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

A total of 120 participants will be randomised into two treatment groups (60 individuals per group). The randomization will be carried out by assigning them consecutively by means of sealed envelopes,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a recent diagnosis of diabetes* (6.5 percent or fasting plasma glucose (FPG) >126 mg/dl twice, or a 2-hour plasma glucose value after a 75-g oral glucose tolerance test >200 mg/dl.

Exclusion criteria

Exclusion criteria: 1. Subjects diagnosed with type 1 diabetes (insulin-dependent), gestational diabetes, maturity-onset diabetes of the young and maternal inherited diabetes and deafness 2. Subjects with any serious chronic disease, alcoholism or other drug addiction, or gastrointestinal diseases that prevent an adequate diet 3. Those who take vitamins or nutritional supplements during the month prior to the study 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Glucose and glycated haemoglobin measured using glucose oxidase method at baseline, 1, 2 and 3 months 2. Lipid metabolism measured using enzymatic procedures at baseline, 1, 2 and 3 months 3. Weight recorded with participants in light clothing without shoes or accessories, using a high-quality calibrated scale at baseline and each week for 3 months 4. Waist circumference measured midway between the lowest rib and the iliac crest at baseline and each week for 3 months 5. Height measured with a wall-mounted stadiometer at baseline 6. BMI calculated as weight (kg) divided by the square of height (m2) at baseline, 1, 2 and 3 months 7. Stress relief and dealing with psychological issues measured at baseline, 1, 2 and 3 months, through different validated tests: 7.1. The 14-item dietary screening questionnaire 7.2. The International Physical Activity Questionnaire (IPAQ) 7.3. The Spanish version and the Short Form-36 Health Survey (SF-36) 7.4. The Hospital Anxiety and Depression Scale (HADS) 7.5. The ‘Life Orientation Test’ (LOT) 7.6. The Duke-UNK functional social support questionnaire (DASI)	—

Measure

Time frame

1. Glucose and glycated haemoglobin measured using glucose oxidase method at baseline, 1, 2 and 3 months 2. Lipid metabolism measured using enzymatic procedures at baseline, 1, 2 and 3 months 3. Weight recorded with participants in light clothing without shoes or accessories, using a high-quality calibrated scale at baseline and each week for 3 months 4. Waist circumference measured midway between the lowest rib and the iliac crest at baseline and each week for 3 months 5. Height measured with a wall-mounted stadiometer at baseline 6. BMI calculated as weight (kg) divided by the square of height (m2) at baseline, 1, 2 and 3 months 7. Stress relief and dealing with psychological issues measured at baseline, 1, 2 and 3 months, through different validated tests: 7.1. The 14-item dietary screening questionnaire 7.2. The International Physical Activity Questionnaire (IPAQ) 7.3. The Spanish version and the Short Form-36 Health Survey (SF-36) 7.4. The Hospital Anxiety and Depression Scale (HADS) 7.5. The ‘Life Orientation Test’ (LOT) 7.6. The Duke-UNK functional social support questionnaire (DASI)

—

Secondary

Measure	Time frame
1. Stress relief and quality of life measured through different validated tests: 1.1. Energy measured using the 14-item dietary screening questionnaire, the International Physical Activity Questionnaire (IPAQ), the Spanish version and the Short Form-36 Health Survey (SF-36), at baseline, 1, 2 and 3 months 1.2. Happiness measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 1, 2 and 3 months 1.3. Positivity measured using the ‘Life Orientation Test’ (LOT) at baseline, 1, 2 and 3 months 1.4. Social support measured using the Duke-UNK functional social support questionnaire (DASI) at baseline, 1, 2 and 3 months 1.5. Work-life balance measured using the Short Form-36 Health Survey (SF-36), at baseline, 1, 2 and 3 months 2. Physical activity measured using the International Physical Activity Questionnaire (IPAQ), Spanish version at baseline, 1, 2 and 3 months	—

Measure

Time frame

1. Stress relief and quality of life measured through different validated tests: 1.1. Energy measured using the 14-item dietary screening questionnaire, the International Physical Activity Questionnaire (IPAQ), the Spanish version and the Short Form-36 Health Survey (SF-36), at baseline, 1, 2 and 3 months 1.2. Happiness measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 1, 2 and 3 months 1.3. Positivity measured using the ‘Life Orientation Test’ (LOT) at baseline, 1, 2 and 3 months 1.4. Social support measured using the Duke-UNK functional social support questionnaire (DASI) at baseline, 1, 2 and 3 months 1.5. Work-life balance measured using the Short Form-36 Health Survey (SF-36), at baseline, 1, 2 and 3 months 2. Physical activity measured using the International Physical Activity Questionnaire (IPAQ), Spanish version at baseline, 1, 2 and 3 months

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026