The (Cost)Effectiveness of Increasing Protein Intake on Physical Funtioning in Older Adults
- Conditions
- Protein-Energy MalnutritionPhysical Disability
- Interventions
- Other: Dietary adviceOther: Dietary advice and advice on timing
- Registration Number
- NCT03712306
- Lead Sponsor
- VU University of Amsterdam
- Brief Summary
In this RCT with the duration of 6 months among 264 community-dwelling older adults (65+ years) with habitual low protein intake, the investigators will examine the long term (cost) effectiveness of increasing daily protein intake to at least 1.2 gram/kg of adjusted body weight on physical functioning in older adults with low protein intake.
- Detailed Description
In this RCT with the duration of 6 months the investigators will examine the long term (cost) effectiveness of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on physical functioning in older adults with habitual low protein intake. Additionally, the investigators will examine the combined effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity on physical functioning in older adults with habitual low protein intake.
Three sub-studies will be conducted, of which the main objectives are to:
1. Examine the effect of persuasive technology on adherence to consumption of protein rich food products in order to increase protein intake to at least 1.2 g/kg adjusted body weight/d, and to the combination of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity.
2. Examine the effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on faecal and oral microbiota composition in older adults with a habitual low protein intake.
3. Examine the effects of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging in older adults with a habitual low protein intake.
Study design: Randomized controlled trial with the duration of 6 months in two study sites: Amsterdam, the Netherlands and Helsinki, Finland. Stratification by gender and habitual protein intake (low protein (\>=0.9 g/kg BW/day - \<1.0 g/kg BW/day), very low protein (\<0.9 g/kg BW/day)).
Study population: A total of 264 community-dwelling older adults aged ≥ 65 years with an habitual low protein intake (n=132 at each study site).
Intervention: This RCT consists of three groups; two intervention groups and one control group. Intervention group 1 (N=44 at each study site) will receive personalized dietary advice aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d without changing daily energy intake, by regular foods and by provided protein-enriched food products. Intervention group 2 (N=44 at each study site) receives personalized dietary advice similar to group 1 and also receives personalized advice to consume protein rich foods in close proximity of usual physical activity. All groups receive a standard brochure of the Netherlands or Finnish Nutrition Centre with general information about healthy eating habits. The control group (N=44 at each at each study site) receives no further intervention.
Main study parameters/endpoints: The primary outcome of this study is change in walk time on the 400 meter walk test. Secondary outcomes are change in dietary intake (including macro- and micronutrients), malnutrition prevalence, physical performance, mobility limitations, muscle strength, body weight and body composition, frailty status, quality of life, and health care costs.
Statistical analyses:
The collected data at the two study sites will be pooled together.
As a result of randomization at study baseline, we assume that groups are equal regarding demographical and socio-economic variables. If this is not the case, we will adjust for differences between groups at baseline. We will adjust for study site (the Netherlands, Finland) and baseline outcome values. We will present unadjusted and adjusted results.
The main analyses will be based on intention-to-treat principles, but per-protocol analyses will also be conducted as a sensitivity analysis.
Multiple Imputation (MI) using multivariate Imputation by Chained Equations (MICE) will be used to impute missing cost and effect data. For this, the missing values need to be missing at random.
The (cost) effectiveness of two intervention groups will be examined against the control group on the primary outcome walk time on the 400 meter walk test. We will compare outcomes between the respective intervention groups and control group separately to determine whether the two interventions are effective (group 1 versus control group; group 2 versus control group).
We will perform mixed model regression analyses adjusting for confounding variables at baseline and study site as cluster variable. We will not correct for multiple testing but look at the clinical relevance of the outcome.
In addition, we will perform sensitivity analyses leaving out the participants who took part in the persuasive technology sub-study.
\*\*\*\* Update June 2020 \*\*\*\*
Deviation of the protocol
Due to the worldwide spread of Covid-19, the original protocol of the PROMISS prevention trial has been changed for those participants who were still active in the study during the spread (March 16th - June 1st). In consultation with both Medical Ethical boards from Finland and the Netherlands, and PROMISS' ethical advisor, the following changes were applied:
March 2020 \* Starting from March 16 2020, the final follow-up measurement of 80 participants (out of 276) was postponed until further notice.
\* Participants were informed that they would be invited for the final follow-up measurement when the country-specific governmental regulations allowed it.
\* Participants were requested to stick to their habitual diet (control group) or their intervention diet (both intervention groups).
April 2020 \* Final measurements were resumed (through interview by phone) except for the physical measurements.
\* Dietary intake was assessed in the week prior to the phone call measurement.
\* Self-reported body weight was added to the questionnaire.
\* The physical follow-up measurement was still postponed until further notice.
May 2020
\* Data collection was continued by means of questionnaires during the phone call measurement in both Finland and the Netherlands.
June 2020
* Starting from the beginning of June, the physical measurements at the clinic site were also resumed in both Finland and the Netherlands. Those with no health complaints potentially caused by the coronavirus were allowed to visit the clinic site.
* The data collection will finish by July 31, 2020.
We will perform sensitivity analyses excluding those participants who were still active in the study during the spread and thus had their physical follow-up measurement +/- 8 months after the baseline assessment (instead of 6 months).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietary advice Dietary advice Personalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products. Dietary advice and advice on timing Dietary advice and advice on timing Personalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products, as well as advice regarding the consumption of protein rich food products in close proximity of usual physical activity.
- Primary Outcome Measures
Name Time Method 6-month change in walk time on a 400 meter walk test 6 months Change in walk time on a 400 meter walk test
- Secondary Outcome Measures
Name Time Method 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB) 6 months SPPB consists of three tests: repeated chair stands test, 4 meter walk test, and tandem stand test. The total score ranges from 0-12. A higher score indicates better physical functioning.
6-month change in leg strength 6 months Upper leg strength measured by a measurement chair
3, and 6-moths self perceived quality of life 3 and 6 months Quality of life measured using the EuroQol-5D instrument. The EuroQol 5D consists of five questions on a Likert scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Answer categories range from (1) 'no problems' to (5) 'unable to'. An additional thermometer for experienced health is scored on a Visual Analogue scale (VAS), ranging from 0-100. The exact point where the line crosses the VAS is the VAS score. The scores are converted to an index value, which facilitates the calculation of quality-adjusted life years (QALYs) that is used to calculate the cost-effectiveness of the study.
3, and 6-month change in body mass index (BMI) 3 and 6 months Based on measured weight (measured at baseline and after 6 months) and height (measured at baseline) BMI will be calculated as body weight (kg) divided by height (m) squared.
6-month change in hand grip strength 6 months Hand grip strength measured by a hand held dynamometer
6-month change in body composition 6 months Body composition (fat-free mass, skeletal muscle mass and fat mass) will be assessed from bioelectrical impedance using body resistance, reactance, impedance and phase angle. In the Dutch sample only, fat-free mass and fat mass will be directly measured by using densitometry (BODPOD).
3, and 6-moths self-reported mobility limitations (questionnaire) 3 and 6 months Mobility limitations will be assessed by means of a questionnaire; "Because of your health, how much difficulty do you have walking 400 meter?" and "Because of your health, how much difficulty do you have climbing one flight of stairs?" Participants responded using a five level Likert scale: 'No difficulty', 'a little difficulty', 'some difficulty', 'a lot of difficulty', and 'unable to do the activity'.
Incidence of sarcopenia risk 3 and 6 months Incidence of sarcopenia risk will be assessed with the SARC-F questionnaire; how much effort do you experience when 1) lifting and carrying a bag of 4.5 kilo, 2) walking across a room, 3) transferring from a chair or bed, 4) climbing a flight of 10 stairs, and 5) how many times have you fallen in the past year. Answering option include no effort (0 points), a bit of effort (1 point) and a lot of effort (2 points), where a score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.
Incident malnutrition 6 months BMI\<22 kg/m2 and unintentional weight loss \>5% over 6 months
3, and 6-moths health care costs assessed by questionnaire 3 and 6 months To measure health care costs the investigators will use a modified version of the Resource Utilization in Dementia Questionnaire WIMO. This questionnaire contains questions on hospital admissions, prescribed medicine use, care from health professionals, and use of other health care services in the past three months. These are the domains that the investigators might expect changes in due to the intervention.
3, and 6-month change in body weight 3 and 6 months Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale.
Body height baseline Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer.
Incident frailty assessed by the Fried Frailty Index 6 months Frailty will be determined using the 5 criteria of the Fried Frailty Index:
* Self-reported unintentional weight loss: \>4 kg in past 6 months.
* Self-reported exhaustion. Based on two self-reported questions from the Center for Epidemiologic Studies Depression scale on exhaustion in the past week at baseline and follow-up: "I felt that everything I did was an effort" and "I could not get going". Scores ranges from 1 'not at all' to 4 'most of the time'. A score of 3 or 4 on either question indicates exhaustion.
* Weakness: grip strength in the lowest 20% of the study population, adjusted for gender and BMI.
* Slow walking speed: walk time on the 400 meter walk test in the slowest 20% of the study population, adjusted for gender and height.
* Low physical activity: Kilocalories expended/wk based on accelerometer data in the lowest quintile of physical activity for each gender.
Outcome:
No components:robust
1 or 2 components:intermediate/prefrail 3 or more components:frailDietary intake assesed by three 24-hour recalls 3 and 6 months A 24-hour recall is a structured interview intended to capture detailed information about all foods and beverages consumed by the participant in the past 24 hours. Changes in dietary intake (based on data of the 24-hour recalls) enables to investigate compliance; i.e. higher protein intake indicates higher compliance.
Physical activity 3 and 6 months Physical activity will be objectively assessed by means of an accelerometer (Axivity, AX3) during 7 subsequent days after each clinic visit.
Trial Locations
- Locations (2)
Vrije Universiteit Amsterdam
🇳🇱Amsterdam, Noord Holland, Netherlands
University of Helsinki
🇫🇮Helsinki, Finland