ObeseNCT04795375
Physical Activity Counseling After Bariatric Surgery
A study testing Physical Activity counseling in people with Obese and Quality of Life, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study will examine whether providing physical activity counseling and guidance to patients post bariatric surgery, along with long-term personal follow-up for six months after the surgery, may increase the level of physical activity, and it's effect on anthropometric and functional measures. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Quality of Life, Exercise
- What is being tested?
- Physical Activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2021to 1 Mar 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 40 kg/m2 or 35 kg/m2 with comorbidities
- 18 to 50 Years old
- Patient is suitable according to the pre-operative evaluation standards to undergo Bariatric surgery
- Speaks Hebrew/Arabic fluently
Who cannot join
- Cognitive decline or severe psychiatric or mental illness
- Patient undergone bariatric surgery in the past
- Pregnancy or Breastfeeding
- Orthopedic disease that limits training and mobility (such as severe arthritis, injury or fractures)
- Heart disease with a risk to exercise (heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndrome)
- Moderate /severe lung disease or COPD with FEV1 / FVC <70% on a pulmonary function test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Activity Counseling After Bariatric Surgery on the Level of Activity and Anthropometric Measures
This study will examine whether providing physical activity counseling and guidance to patients post bariatric surgery, along with long-term personal follow-up for six months after the surgery, may increase the level of physical activity, and it's effect on anthropometric and functional measures.
Read the detailed description
Bariatric surgery is considered to be most effective in treating morbid obesity for patients with BMI≥40 or BMI≥35 with comorbidity for obesity.
postoperative weight loss following any type of bariatric surgery is largely dependent on the extent to which patients can make and sustain changes in their eating habits and activity level. Adopting physical activity habits can help to optimize outcomes after bariatric surgery, such as contributing to the rate of weight loss after the surgery and maintain lean body mass.
In order to successfully implement a behavioral change regarding the adaptation of healthy lifestyle habits in obese patients, it is vital to promote physical activity counseling after the surgery, and to find an effective intervention that can support habitual physical activity.
The aim of this trial is to examine the effect physical activity counseling after bariatric surgery on the amount and intensity of activity performed, quality of life, anthropometric and functional measures during the first year after surgery.
Up to eighty Participants will be recruited for the trial, and will be randomly assigned to one of the two study arms (Control, Intervention). The intervention group will receive physical activity counseling and guidelines for the following six months after the surgery.
All participants will receive a pedometer to track daily steps for 7 days at different time points before and after the intervention. Additional Measurements will be taken at a pre-surgical baseline assessment and throughout the trial, and will include anthropometric measures (Weight, BMI, and body composition) and functional measures (Handgrip, 6-minute walk test, chair stand-up test).
All participants will fill out a the 7-day international Physical Activity questionnaire, Self-efficacy for physical exercise scale, and SF-36 questionnaire, before and after the intervention.
- Conditions
- Obese, Quality of Life, Exercise, Behavior, Health, Bariatric Surgery
- Being tested
- Physical Activity counseling
- Keywords
- Physical Activity, Exercise
- Medical subject headings
- Obesity, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity counselingBehavioural
The Physical activity counseling techniques will be based on the Self Determination Theory and Five A's (Assess, Advise, Agree, Assist, Arrange). Guidelines for physical activity will include combined aerobic and resistance exercises.
Each participant in the intervention group will receive personal exercise prescriptions in accordance the post-surgical statues and exercise recommendations after bariatric surgery. Participants will receive long term follow-up and accompaniment during the first six months after the surgery, through Personal meetings with a certified nurse, Phone-calls, motivational massages, and Exercise Videos.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive Physical activity counseling and guidance by a certified Nurse during the six months after the surgery, additional to the routine follow-up after bariatric surgery at Hadassah-Ein Kerem Hospital. Receives: Behavioral: Physical Activity counseling |
| Control | No intervention | The control group will receive the routine follow-up followed at Hadassah-Ein Kerem Hospital after bariatric surgery, which includes long term follow-up with the surgeon and a dietitian. Participants at the Control group will receive Physical activity counseling by a certified nurse at the end of trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily Step count
Average daily step count of the last 7 days before each visit
Measured: change from Baseline at up to 26 weeks (end of the intervention phase)
Average daily Step count
Average daily step count of the last 7 days before each visit
Measured: 1 year post-surgery
MET's of Self-reported physical activity
Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity.
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase)
MET's of Self-reported physical activity
Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity.
Measured: 1 year post-surgery
Secondary outcomes (9)
Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Changes in Muscle Mass
Measuring Muscle mass using bioelectrical impedance analysis scale
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
six min walk test
to measure physical funtion,6 min walk test will be assessed in meters
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase)
sit to stand test
test measuring time of 5 repetitions to assesses functional lower extremity strength
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Changes in Handgrip strength test (Kg)
to measure the maximum isometric strength of the hand and forearm muscle in KG
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
changes in Self-efficacy assessed by (SSE)- Self-efficacy for physical exercise scale
Self-efficacy score reported in Self-efficacy for physical exercise scale (score 0-90)
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Changes in Health-related Quality of life assessed by SF-36 Questionnaire
reported in Sf-36 Questionnaire
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase)
Change in total cholesterol, HDL and LDL levels
Results of bloods tests taken at follow-up
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Change in glucose and HbA1c levels
Results of bloods tests taken at follow-up
Measured: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ram Elazary, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795375
- Sponsor's protocol ID
- BPA-0965-HMO
- Status last verified
- May 2022
- First submitted
- 4 Mar 2021
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity Counseling After Bariatric Surgery on the Level of Activity and Anthropometric Measures
- ClinicalTrials.gov ID
- NCT04795375
- Acronym / sponsor ID
- BPA-0965-HMO
- Conditions
- Obese, Quality of Life, Exercise, Behavior, Health, Bariatric Surgery
- Keywords
- Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 12 Mar 2021 (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.
This study will examine whether providing physical activity counseling and guidance to patients post bariatric surgery, along with long-term personal follow-up for six months after the surgery, may increase the level of physical activity, and it's effect on anthropometric and functional measures.
Detailed description
Bariatric surgery is considered to be most effective in treating morbid obesity for patients with BMI≥40 or BMI≥35 with comorbidity for obesity.
postoperative weight loss following any type of bariatric surgery is largely dependent on the extent to which patients can make and sustain changes in their eating habits and activity level. Adopting physical activity habits can help to optimize outcomes after bariatric surgery, such as contributing to the rate of weight loss after the surgery and maintain lean body mass.
In order to successfully implement a behavioral change regarding the adaptation of healthy lifestyle habits in obese patients, it is vital to promote physical activity counseling after the surgery, and to find an effective intervention that can support habitual physical activity.
The aim of this trial is to examine the effect physical activity counseling after bariatric surgery on the amount and intensity of activity performed, quality of life, anthropometric and functional measures during the first year after surgery.
Up to eighty Participants will be recruited for the trial, and will be randomly assigned to one of the two study arms (Control, Intervention). The intervention group will receive physical activity counseling and guidelines for the following six months after the surgery.
All participants will receive a pedometer to track daily steps for 7 days at different time points before and after the intervention. Additional Measurements will be taken at a pre-surgical baseline assessment and throughout the trial, and will include anthropometric measures (Weight, BMI, and body composition) and functional measures (Handgrip, 6-minute walk test, chair stand-up test).
All participants will fill out a the 7-day international Physical Activity questionnaire, Self-efficacy for physical exercise scale, and SF-36 questionnaire, before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical Activity counselingThe intervention group will receive Physical activity counseling and guidance by a certified Nurse during the six months after the surgery, additional to the routine follow-up after bariatric surgery at Hadassah-Ein Kerem Hospital. |
| Control | No intervention | –The control group will receive the routine follow-up followed at Hadassah-Ein Kerem Hospital after bariatric surgery, which includes long term follow-up with the surgeon and a dietitian. Participants at the Control group will receive Physical activity counseling by a certified nurse at the end of trial. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥ 40 kg/m2 or 35 kg/m2 with comorbidities
- 18 to 50 Years old
- Patient is suitable according to the pre-operative evaluation standards to undergo Bariatric surgery
- Speaks Hebrew/Arabic fluently
Key exclusion criteria (6 listed)
- Cognitive decline or severe psychiatric or mental illness
- Patient undergone bariatric surgery in the past
- Pregnancy or Breastfeeding
- Orthopedic disease that limits training and mobility (such as severe arthritis, injury or fractures)
- Heart disease with a risk to exercise (heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndrome)
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 |
|---|---|---|
| Physical Activity counselingThe Physical activity counseling techniques will be based on the Self Determination Theory and Five A's (Assess, Advise, Agree, Assist, Arrange). Guidelines for physical activity will include combined aerobic and resistance exercises. Each participant in the intervention group will receive personal exercise prescriptions in accordance the post-surgical statues and exercise recommendations after bariatric surgery. Participants will receive long term follow-up and accompaniment during the first six months after the surgery, through Personal meetings with a certified nurse, Phone-calls, motivational massages, and Exercise Videos. | Behavioural | Intervention |
Primary outcome
Average daily Step count
Time frame: change from Baseline at up to 26 weeks (end of the intervention phase)
Average daily step count of the last 7 days before each visit
Average daily Step count
Time frame: 1 year post-surgery
Average daily step count of the last 7 days before each visit
MET's of Self-reported physical activity
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase)
Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity.
MET's of Self-reported physical activity
Time frame: 1 year post-surgery
Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity.
9 secondary outcomes
Changes in BMI
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Changes in Muscle Mass
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
six min walk test
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase)
sit to stand test
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Changes in Handgrip strength test (Kg)
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
changes in Self-efficacy assessed by (SSE)- Self-efficacy for physical exercise scale
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Changes in Health-related Quality of life assessed by SF-36 Questionnaire
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase)
Change in total cholesterol, HDL and LDL levels
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Change in glucose and HbA1c levels
Time frame: Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity counseling in people with Obese and Quality of Life, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 6 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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily Step count (time frame: change from Baseline at up to 26 weeks (end of the intervention phase)). The study lists 4 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 17 May 2022.