Lifestyle, HealthyNELIPNCT06187675
A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach
A study testing Nutrition and Exercise Lifestyle Intervention Program in people with Lifestyle, Healthy and Pregnancy Related, run by Western University, Canada at 1 site in Canada.
Trial summary
Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Healthy, Pregnancy Related, Adherence, Treatment
- What is being tested?
- Nutrition and Exercise Lifestyle Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 12 to 18 weeks of pregnancy
- a singleton fetus
- medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component
Who cannot join
- inability to walk
- serious medical problems
- high blood pressure
- uncontrolled chest pain
- uncontrolled symptomatic lung disease
- diabetes before pregnancy
Show all 9Show fewer
- a history of recreational substance use disorder
- any contraindication to exercise
- enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
London, Ontario, N6A 3K7
Michelle F Mottola, PhD, 519-661-2111 ext. 88366, mmottola@uwo.ca
Michelle F Mottola, PhD
About this study
Official title: A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions
Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.
Read the detailed description
Investigators are using a pseudo randomized yoked design and will include two groups: choice of intervention strategy or no-choice. If the individual is randomized to no choice, then the next person would get a choice and the no choice person would be assigned to the group yoked (matched) to the person with a choice. Participants assigned to the choice group will choose one of three intervention strategies provided; either Group A (receiving both nutrition and exercise simultaneously), B (starting with nutrition and receiving exercise sequentially followed by nutrition starting at 25 weeks) or C (starting with nutrition first and then introducing exercise sequentially at 25 weeks). All groups will follow the full NELIP until delivery. Participants in the no-choice group will be yoked (matched) to a participant in the choice group and receive the strategy that their yoked counterparts chose.
Nutrition component of NELIP: This component is a modified gestational diabetic meal plan that has four general goals tailored to the participant: (1) to achieve approximately 2000 kcal of energy per day. The determination of the amount of kcal consumed per day will consider the participant's intake from the dietary assessment. There also must not be a restriction of calories that exceeds 30% of their total energy intake; (2) participants will consume approximately 200-250g/day of carbohydrates, accounting for approximately 40-55% of total energy intake. Carbohydrate intake will be distributed throughout three meals and four snacks daily. The nutritionist will educate participants about the importance of complex and low-glycemic index carbohydrates through the one-on-one session; (3) fat and protein intake will be approximately 30% and 20-30% of total energy intake, respectively; (4) achieve appropriate micronutrient and fluid intake for pregnancy. This will be monitored by a weekly 24 hour food intake record.
Exercise component of NELIP: This is a walking program that comprises of 1 weekly supervised session on a treadmill or outside and participants will be recommended to walk 2 to 3 additional times per week. The walking program will start at 25 minutes per session, 3 to 4 times weekly, and increase by 2 minutes per week until 40 minutes and then maintained until delivery. This will be monitored by a wrist monitoring device. The primary outcome is adherence measured weekly using a published adherence protocol using a point system. Secondary outcomes are participant satisfaction to the program and health outcomes: weekly weight gain, calculated EGWG, and pregnancy outcomes (birth weight length, infant anthropometrics, APGAR scores and delivery complications). At 2, 6 and 12 months of age the maternal-infant dyad will return to the lab and infant morphometric measurements recorded from birth will be repeated.
- Conditions
- Lifestyle, Healthy, Pregnancy Related, Adherence, Treatment, Nutrition, Healthy, Weight Gain, Maternal
- Being tested
- Nutrition and Exercise Lifestyle Intervention Program
- Keywords
- pregnancy, lifestyle, nutrition, exercise, adherence
- Medical subject headings
- Treatment Adherence and Compliance, Gestational Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Exercise Lifestyle Intervention ProgramBehavioural
Also called NELIP
Nutrition and Exercise components for pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Choice | Active comparator | Participants will be given a choice of 3 strategies; Group A - they receive both nutrition and exercise components simultaneously, Group B - they receive the nutrition component first followed by introduction of the exercise component sequentially, or Group C - they receive the exercise component first followed by introduction of the nutrition component sequentially. Receives: Behavioral: Nutrition and Exercise Lifestyle Intervention Program |
| No choice | Experimental | Participants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice. Receives: Behavioral: Nutrition and Exercise Lifestyle Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the intervention strategy
Percent of participants adherent to the strategies measured by a published Adherence Scale giving a score out of 3 for each component (nutrition and exercise).
Measured: Measured once per week from baseline (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation)
Secondary outcomes (13)
Participant satisfaction
Satisfaction Survey assessed on a 5-point Likert scale; ranging from 1 for very unsatisfied to 5 for very satisfied.
Measured: Measured at 34-36 weeks of pregnancy at the end of the intervention
Gestational weight gain
Weight gained measured in kg and compared to the Institute of Medicine 2009 weight gain guidelines
Measured: Measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Birth weight
Birth weight (measured in kg)
Measured: Measured within 6 to 18 hours after delivery
Birth length
Birth Length (measured in cms)
Measured: Measured within 6 to 18 hours after delivery
Birth circumferences
Newborn circumferences (arm, forearm, thigh, leg, abdomen, chest, and head - measured in cm)
Measured: Measured within 6 to 18 hours after delivery
Birth skinfolds
Newborn skinfolds (biceps, triceps, subscapular, suprailiac, anterior thigh - measured in mm)
Measured: Measured within 6 to 18 hours after delivery
Pregnancy outcome
APGAR scores (measured out of 10 at 1 minutes and 5 minutes after birth)
Measured: Measured within 6 to 18 hours after delivery
Pregnancy complications
Pregnancy complications (recorded)
Measured: Measured within 6 to 18 hours after delivery
Postpartum body weight
Participant body weight (measured in kg)
Measured: 2, 6 and 12 months after birth
Follow-up Infant weight
Infant weight (measured in kg)
Measured: 2, 6 and 12 months after birth
Follow-up Infant length
Infant length (measured in cm)
Measured: 2, 6 and 12 months after birth
Follow-up Infant Girths
Infant circumferences (arm, forearm, thigh, leg, abdomen, chest, head - measured in cm)
Measured: 2, 6 and 12 months after birth
Follow-up Infant adiposity
Infant skinfold measurements (biceps, triceps, subscapular, suprailiac, anterior thigh - measured in mm)
Measured: 2, 6 and 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lifestyle, HealthyStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pseudo randomized yoked design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Mottola, Western University, Canada
- Investigators
- Michelle F Mottola, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187675
- Sponsor's protocol ID
- 123317
- Acronym
- NELIP
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified data may be shared after publication
Publications
Nagpal TS, Prapavessis H, Campbell CG, de Vrijer B, Bgeginski R, Hosein K, Paplinskie S, Manley M, Mottola MF. Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial. Int J Behav Med. 2020 Feb;27(1):108-118. doi: 10.1007/s12529-019-09840-0.
PubMed 31872340Nagpal TS, Prapavessis H, Campbell C, Mottola MF. Measuring Adherence to a Nutrition and Exercise Lifestyle Intervention: Is Program Adherence Related to Excessive Gestational Weight Gain? Behav Anal Pract. 2017 May 17;10(4):347-354. doi: 10.1007/s40617-017-0189-5. eCollection 2017 Dec.
PubMed 29214130Mottola MF, Giroux I, Gratton R, Hammond JA, Hanley A, Harris S, McManus R, Davenport MH, Sopper MM. Nutrition and exercise prevent excess weight gain in overweight pregnant women. Med Sci Sports Exerc. 2010 Feb;42(2):265-72. doi: 10.1249/MSS.0b013e3181b5419a.
PubMed 20083959
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Participant Choice Approach to Improve Adherence and Investigate Pregnancy Outcomes to Lifestyle Interventions
- ClinicalTrials.gov ID
- NCT06187675
- Acronym / sponsor ID
- NELIP / 123317
- Conditions
- Lifestyle, Healthy, Pregnancy Related, Adherence, Treatment, Nutrition, Healthy, Weight Gain, Maternal
- Keywords
- pregnancy, lifestyle, nutrition, exercise, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 2 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.
Interventions that target excessive gestational weight gain (EGWG) with nutrition and exercise behavior change struggle with low program adherence. The investigators recently examined adherence in a randomized controlled trial to a previously established lifestyle program called the Nutrition and Exercise Lifestyle Intervention Program (NELIP) and found that those individuals with high adherence to the program were more likely to prevent EGWG. Perhaps offering participants a choice to intervention strategies may improve adherence. The current research question is: What impact does participant choice have on adherence to the introduction of nutrition and exercise components during 3 intervention strategies offered to pregnant individuals compared to no choice and does choice maintain pregnancy health outcomes? The strategies are: Group A - introducing both the nutrition and exercise components simultaneous at baseline (12-18 weeks of pregnancy) that is followed to delivery (NELIP); Group B - introducing the nutrition component first and then at 25 weeks adding the exercise component; or Group C - starting with the exercise component first, followed with introducing the nutrition component at 25 weeks. Both Groups B and C follow the full NELIP from 25 weeks to delivery (final intervention measures will occur at 34-36 weeks gestation). Follow-up will occur at birth (6-18 hours), 2, 6 and 12 months post delivery.
Detailed description
Investigators are using a pseudo randomized yoked design and will include two groups: choice of intervention strategy or no-choice. If the individual is randomized to no choice, then the next person would get a choice and the no choice person would be assigned to the group yoked (matched) to the person with a choice. Participants assigned to the choice group will choose one of three intervention strategies provided; either Group A (receiving both nutrition and exercise simultaneously), B (starting with nutrition and receiving exercise sequentially followed by nutrition starting at 25 weeks) or C (starting with nutrition first and then introducing exercise sequentially at 25 weeks). All groups will follow the full NELIP until delivery. Participants in the no-choice group will be yoked (matched) to a participant in the choice group and receive the strategy that their yoked counterparts chose.
Nutrition component of NELIP: This component is a modified gestational diabetic meal plan that has four general goals tailored to the participant: (1) to achieve approximately 2000 kcal of energy per day. The determination of the amount of kcal consumed per day will consider the participant's intake from the dietary assessment. There also must not be a restriction of calories that exceeds 30% of their total energy intake; (2) participants will consume approximately 200-250g/day of carbohydrates, accounting for approximately 40-55% of total energy intake. Carbohydrate intake will be distributed throughout three meals and four snacks daily. The nutritionist will educate participants about the importance of complex and low-glycemic index carbohydrates through the one-on-one session; (3) fat and protein intake will be approximately 30% and 20-30% of total energy intake, respectively; (4) achieve appropriate micronutrient and fluid intake for pregnancy. This will be monitored by a weekly 24 hour food intake record.
Exercise component of NELIP: This is a walking program that comprises of 1 weekly supervised session on a treadmill or outside and participants will be recommended to walk 2 to 3 additional times per week. The walking program will start at 25 minutes per session, 3 to 4 times weekly, and increase by 2 minutes per week until 40 minutes and then maintained until delivery. This will be monitored by a wrist monitoring device. The primary outcome is adherence measured weekly using a published adherence protocol using a point system. Secondary outcomes are participant satisfaction to the program and health outcomes: weekly weight gain, calculated EGWG, and pregnancy outcomes (birth weight length, infant anthropometrics, APGAR scores and delivery complications). At 2, 6 and 12 months of age the maternal-infant dyad will return to the lab and infant morphometric measurements recorded from birth will be repeated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pseudo randomized yoked design
| Arm | Type | Receives |
|---|---|---|
| Choice | Active comparator | Behavioral: Nutrition and Exercise Lifestyle Intervention ProgramParticipants will be given a choice of 3 strategies; Group A - they receive both nutrition and exercise components simultaneously, Group B - they receive the nutrition component first followed by introduction of the exercise component sequentially, or Group C - they receive the exercise component first followed by introduction of the nutrition component sequentially. |
| No choice | Experimental | Behavioral: Nutrition and Exercise Lifestyle Intervention ProgramParticipants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 12 to 18 weeks of pregnancy
- a singleton fetus
- medically screened with the Get Active Questionnaire for Pregnancy to determine eligibility for participation in the exercise component
Key exclusion criteria (9 listed)
- inability to walk
- serious medical problems
- high blood pressure
- uncontrolled chest pain
- uncontrolled symptomatic lung disease
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 |
|---|---|---|
| Nutrition and Exercise Lifestyle Intervention ProgramAlso: NELIPNutrition and Exercise components for pregnancy | Behavioural | Choice, No choice |
Primary outcome
Adherence to the intervention strategy
Time frame: Measured once per week from baseline (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation)
Percent of participants adherent to the strategies measured by a published Adherence Scale giving a score out of 3 for each component (nutrition and exercise).
13 secondary outcomes
Participant satisfaction
Time frame: Measured at 34-36 weeks of pregnancy at the end of the intervention
Gestational weight gain
Time frame: Measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Birth weight
Time frame: Measured within 6 to 18 hours after delivery
Birth length
Time frame: Measured within 6 to 18 hours after delivery
Birth circumferences
Time frame: Measured within 6 to 18 hours after delivery
Birth skinfolds
Time frame: Measured within 6 to 18 hours after delivery
Pregnancy outcome
Time frame: Measured within 6 to 18 hours after delivery
Pregnancy complications
Time frame: Measured within 6 to 18 hours after delivery
Postpartum body weight
Time frame: 2, 6 and 12 months after birth
Follow-up Infant weight
Time frame: 2, 6 and 12 months after birth
Follow-up Infant length
Time frame: 2, 6 and 12 months after birth
Follow-up Infant Girths
Time frame: 2, 6 and 12 months after birth
Follow-up Infant adiposity
Time frame: 2, 6 and 12 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 31872340Nagpal TS, Prapavessis H, Campbell CG, de Vrijer B, Bgeginski R, Hosein K, Paplinskie S, Manley M, Mottola MF. Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial. Int J Behav Med. 2020 Feb;27(1):108-118. doi: 10.1007/s12529-019-09840-0.
- Background: PubMed 29214130Nagpal TS, Prapavessis H, Campbell C, Mottola MF. Measuring Adherence to a Nutrition and Exercise Lifestyle Intervention: Is Program Adherence Related to Excessive Gestational Weight Gain? Behav Anal Pract. 2017 May 17;10(4):347-354. doi: 10.1007/s40617-017-0189-5. eCollection 2017 Dec.
- Background: PubMed 20083959Mottola MF, Giroux I, Gratton R, Hammond JA, Hanley A, Harris S, McManus R, Davenport MH, Sopper MM. Nutrition and exercise prevent excess weight gain in overweight pregnant women. Med Sci Sports Exerc. 2010 Feb;42(2):265-72. doi: 10.1249/MSS.0b013e3181b5419a.
- Exercise and Pregnancy Laboratory WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. deidentified data may be shared after publication
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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.
Michelle F Mottola, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Exercise Lifestyle Intervention Program in people with Lifestyle, Healthy and Pregnancy Related, run by Western University, Canada at 1 site in Canada.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 5 Mar 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle F Mottola, PhD (519-661-2111 ext. 85480, mmottola@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the intervention strategy (time frame: Measured once per week from baseline (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187675, which also lists 3 linked publications.
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 Mar 2024.