Obesity2EATNCT06192732
Environmentally Sustainable Nutrition for Older Adults (55+) With Obesity
A study testing A more plant-based diet during weight loss in people with Obesity and Aging, run by Amsterdam University of Applied Sciences.
Trial summary
The objective of the pilot study (feasibility study) is to assess the acceptability and feasibility of the developed 2EAT dietary treatment in obese older adults (55+). For ecological reasons, the goal of the dietary treatment plan is to achieve an intake of 60% plant-based proteins in older adults (55+) in a healthy… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- What is being tested?
- A more plant-based diet during weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 55 or older
- Are obese: have a BMI of >30 kg/m2 or BMI >27 kg/m2 and waist circumference >88 cm (women) or >102 cm (men)
- Living independently (not in a health facility)
- The willingness that the general practitioner will be notified of study participation
- Written informed consent
- Willingness to comply with the protocol
- Consent of the study physician
Who cannot join
- Inability to understand the Dutch language
- Cognitive impairment (MMSE <15)
- Use of total or partial parenteral nutrition (TPN)
- Alcohol or drug abuse in the opinion of the investigator
- Current enrolment in a fixed rehabilitation program or other intervention studies
- Palliative treatment or a life expectancy of ≤ 3 months
Show all 10Show fewer
- Following a vegan (100% plant-based) diet
- Active medical treatment interfering with this intervention (e.g. cancer patients receiving systemic and immune therapy)
- Physical disabled: unable to meet the general daily exercise guideline for adults
- Planned a holiday during the intervention period and is unable to attend group- or individual sessions for > 1 week
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Environmentally Sustainable Nutrition for Older Adults (55+) With Obesity: a Pilot Study
The objective of the pilot study (feasibility study) is to assess the acceptability and feasibility of the developed 2EAT dietary treatment in obese older adults (55+).
For ecological reasons, the goal of the dietary treatment plan is to achieve an intake of 60% plant-based proteins in older adults (55+) in a healthy and nutritionally adequate way during a period of weight loss. The investigators developed the new dietary treatment plan for 6 months (RCT). To further optimize the new treatment plan the 2EAT study includes this feasibility study with a duration of 8 weeks.
Read more
In the feasibility study, the effect of a more plant-based hypocaloric diet on the protein intake of older adults (55+) with obesity is evaluated. To assess the feasibility of the treatment plan, 20 obese older adults will follow the newly developed dietary treatment for 8 weeks. The participants will be guided by experienced dieticians that are part of the study consortium, in their dietetic practice. All dieticians will be trained to execute the 2EAT dietary treatment plan.
The desired effect of the treatment is that participants change their protein intake and achieve an intake of 1.2 g/kg/d of which 60% is from plant-based sources. Additionally, the experience of both the older adults as well as the experience of the dieticians will be monitored during the 8 weeks of intervention. During 8 weeks there will be continuous monitoring of the implementation of the treatment plan by keeping logbooks (dieticians), and measurement of the food intake of the participants. When participants deviate from the diet, the dietician must make timely adjustments with available behavioral techniques. The primary outcome of the feasibility phase is the protein intake: source (plant-based vs. animal-based), amount (g/kg/day) and protein quality per meal (amino acid score). Secondary outcomes are the body weight and BMI of participants and qualitative information about the experience of participants and dieticians with the use of the new treatment plan. Dieticians are professionals in working with older clients with obesity during a weight loss program, and are competent to execute the treatment plan and additionally monitor and make adjustments to coach the participant towards the desired diet and goal. Findings and experiences from the 8-week feasibility study will be used to further improve the 2EAT dietary treatment. The optimized dietary plan will eventually be used in the RCT study.
- Being tested
- A more plant-based diet during weight loss
- Keywords
- Obesity, Older adults, Healthy ageing, Sustainability, Plant-based protein, Plant-based diet, Sustainable diets, Dietary counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A more plant-based diet during weight lossBehavioural
Participants receive dietary counseling on a more plant-based diet during weight loss. They will be counseled by a dietician to increase their plant-based protein intake up to 60%, focusing on 1.2 grams of protein per kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| More plant-based diet | Experimental | Participants receive the dietary counselling focused on a more plant-based diet during weight loss Receives: Behavioral: A more plant-based diet during weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility
The objective of the feasibility study is to assess the feasibility of the developed 2EAT dietary treatment in obese older adults (55+). The feasibility focusses on the ratio plant-based and animal-based protein, where it is aimed to reach 60% plant-based proteins at endline (week 9). This will be investigated via 3-day dietary records (measured at baseline and endline).
Measured: Baseline (week 0) and endline (week 9)
Assess the acceptability
The objective of the feasibility study is to assess the acceptability of the developed 2EAT dietary treatment in obese older adults (55+). This will be investigated via focus groups. Focus groups will be organized for participants and dieticians separately at endline (week 9).
Measured: Endline (week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Weijs, Principal investigator, Amsterdam University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192732
- Sponsor's protocol ID
- RAAK.PRO04.033
- Acronym
- 2EAT
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmentally Sustainable Nutrition for Older Adults (55+) With Obesity: a Pilot Study
- ClinicalTrials.gov ID
- NCT06192732
- Acronym / sponsor ID
- 2EAT / RAAK.PRO04.033
- Keywords
- Obesity, Older adults, Healthy ageing, Sustainability, Plant-based protein, Plant-based diet, Sustainable diets, Dietary counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amsterdam University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the pilot study (feasibility study) is to assess the acceptability and feasibility of the developed 2EAT dietary treatment in obese older adults (55+).
For ecological reasons, the goal of the dietary treatment plan is to achieve an intake of 60% plant-based proteins in older adults (55+) in a healthy and nutritionally adequate way during a period of weight loss. The investigators developed the new dietary treatment plan for 6 months (RCT). To further optimize the new treatment plan the 2EAT study includes this feasibility study with a duration of 8 weeks.
In the feasibility study, the effect of a more plant-based hypocaloric diet on the protein intake of older adults (55+) with obesity is evaluated. To assess the feasibility of the treatment plan, 20 obese older adults will follow the newly developed dietary treatment for 8 weeks. The participants will be guided by experienced dieticians that are part of the study consortium, in their dietetic practice. All dieticians will be trained to execute the 2EAT dietary treatment plan.
The desired effect of the treatment is that participants change their protein intake and achieve an intake of 1.2 g/kg/d of which 60% is from plant-based sources. Additionally, the experience of both the older adults as well as the experience of the dieticians will be monitored during the 8 weeks of intervention. During 8 weeks there will be continuous monitoring of the implementation of the treatment plan by keeping logbooks (dieticians), and measurement of the food intake of the participants. When participants deviate from the diet, the dietician must make timely adjustments with available behavioral techniques. The primary outcome of the feasibility phase is the protein intake: source (plant-based vs. animal-based), amount (g/kg/day) and protein quality per meal (amino acid score). Secondary outcomes are the body weight and BMI of participants and qualitative information about the experience of participants and dieticians with the use of the new treatment plan. Dieticians are professionals in working with older clients with obesity during a weight loss program, and are competent to execute the treatment plan and additionally monitor and make adjustments to coach the participant towards the desired diet and goal. Findings and experiences from the 8-week feasibility study will be used to further improve the 2EAT dietary treatment. The optimized dietary plan will eventually be used in the RCT study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| More plant-based diet | Experimental | Behavioral: A more plant-based diet during weight lossParticipants receive the dietary counselling focused on a more plant-based diet during weight loss |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 55 or older
- Are obese: have a BMI of >30 kg/m2 or BMI >27 kg/m2 and waist circumference >88 cm (women) or >102 cm (men)
- Living independently (not in a health facility)
- The willingness that the general practitioner will be notified of study participation
- Written informed consent
Key exclusion criteria (10 listed)
- Inability to understand the Dutch language
- Cognitive impairment (MMSE <15)
- Use of total or partial parenteral nutrition (TPN)
- Alcohol or drug abuse in the opinion of the investigator
- Current enrolment in a fixed rehabilitation program or other intervention studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A more plant-based diet during weight lossParticipants receive dietary counseling on a more plant-based diet during weight loss. They will be counseled by a dietician to increase their plant-based protein intake up to 60%, focusing on 1.2 grams of protein per kg body weight. | Behavioural | More plant-based diet |
Primary outcome
Assess the feasibility
Time frame: Baseline (week 0) and endline (week 9)
The objective of the feasibility study is to assess the feasibility of the developed 2EAT dietary treatment in obese older adults (55+). The feasibility focusses on the ratio plant-based and animal-based protein, where it is aimed to reach 60% plant-based proteins at endline (week 9). This will be investigated via 3-day dietary records (measured at baseline and endline).
Assess the acceptability
Time frame: Endline (week 9)
The objective of the feasibility study is to assess the acceptability of the developed 2EAT dietary treatment in obese older adults (55+). This will be investigated via focus groups. Focus groups will be organized for participants and dieticians separately at endline (week 9).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Weijs principal investigator
Amsterdam University of Applied Sciences
Questions about this trial
What is this clinical trial studying?
A study testing A more plant-based diet during weight loss in people with Obesity and Aging, run by Amsterdam University of Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Wildemast (+31623492734, s.wildemast@hva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility (time frame: Baseline (week 0) and endline (week 9)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.