Improving dietary and physical activity behaviours in women in midlife (aged 40 - 65 years) Nutritional, Metabolic, Endocrine
Conditions
Interventions
This feasibility trial aims to implement and evaluate a 21-day intervention programme to improve healthy eating and increase physical activity in women in midlife (aged 40-65 years). A mixed-methods d
Sponsors
University of Westminster
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who are between ages 40 – 65 years 2. Women who are UK residents 3. Ability to converse in English
Exclusion criteria
Exclusion criteria: 1. Treatment for a serious mental health condition 2. Pregnancy, or trying to get pregnant 3. Serious life-threatening illness (i.e., cancer, heart failure) 4. Currently enrolled in another lifestyle study 5. Inability to converse in English 6. Unable to wear a fitness tracker on the wrist for 21 consecutive days, for a minimum of 8 hours/day 7. Unable to refrain from wearing any other fitness trackers or lifestyle apps (specifically for diet and physical activity), for the duration of the study 8. Unable to engage in the study for 21 consecutive days without the need to travel internationally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following feasibility aspects of the study are measured using: 1. Recruitment rate: the number of participants who are recruited, represented as a percentage of the number of participants who show interest, at baseline 2. Attrition rate: the percentage of participants who withdraw after signing Informed Consent at 3 weeks. 3. Retention rate: the percentage of participants who complete all programme components and evaluation measurements at 3 weeks 4. Compliance rates: represented by: 4.1. Percentage of participants who fully comply with wearing the provided accelerometer measured using a recorded minimum of 8-hrs of daily Garmin data at 3 weeks 4.2. Percentage of participants who record daily physical activity and sleep, measured using recorded 24-hr daily Garmin data at 3 weeks 4.3. Percentage of participants who complete daily mEMA surveys (each prompt even if not all subsections) at 3 weeks 4.4. Percentage of participants who review mEMA education content at 3 weeks 4.5. Percentage of participants who complete the study surveys at 1 week, and at 3 weeks 4.6. Percentage of patients who complete the evaluation (exit) questionnaire at 3 weeks 5. Response rate: represented by 5.1. The percentage of daily completed surveys out of the total number of surveys administered to the participant over the entire study period. Responses will be considered complete if the participants answer every question on the sub-surveys 5.2. The amount of time spent reading the mEMA education content on healthy eating, physical activity, and menopause 5.3. Wearing the Garmin fitness tracker for at least 8-hrs daily for 3 weeks The mean response rate for the sample will be computed as the arithmetic mean of the participant’s individual response rates. 6. Acceptability of the study to all participants measured using the evaluation (exit) questionnaire (based on TFA), including measured items and quotes from the participants, immediately after completing their 21-day programme | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of daily steps walked, measured using accelerometer at baseline (a 7-day average), and daily for 14 days during the intervention period. 2. Minutes of moderate-intensity activity measured using an accelerometer at baseline (a 7-day average), and daily for 14 days during the intervention period. A pre-study baseline and post-study questionnaire (IPAQ-SF) will also capture this self-reported data. 3. Sleep length and quality (reduced awake time) measured using an accelerometer at baseline (a 7-day average), and daily for 14 days during the intervention period. A pre-study baseline and post-study questionnaire (PSQI) will also capture this self-reported data. 4. Hydration measured daily using mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study questionnaire (SFFFQ) will also capture this self-reported data. 5. Caffeinated beverage intake measured daily using mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study questionnaire (SFFFQ) will also capture this self-reported data. 6. Alcoholic beverage consumption measured daily using mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study questionnaire (SFFFQ) will also capture this self-reported data. 7. Consumption of portions of fruit and vegetables measured daily using mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study questionnaire (SFFFQ) will also capture this self-reported data. 8. Number of skipped meals measured daily using mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study questionnaire (SFFFQ) will also capture this self-reported data. 9. Number of snacks consumed measured daily using mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study questionnaire (SFFFQ) will also capture this self-reported data. 10. Menopausal symptoms, specifically fatigue, measured using daily using the mEMA surveys for 14 days. A pre-study baseline questionnaire and post-study question | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed