An interventional study of Nutrition and Exercise Lifestyle Intervention Program in Lifestyle, Healthy, Pregnancy Related and Adherence, Treatment, sponsored by Western University, Canada. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Western University, Canada · Not applicable, Interventional, and Prevention
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.
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.
351 studies on the registry are indexed under Treatment Adherence and Compliance; 109 are open to participants now.
This study's planned enrollment of 120 is above the median of 82 across 271 interventional studies indexed under Treatment Adherence and Compliance.
Browse Treatment Adherence and Compliance studies →Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Nutrition and Exercise Lifestyle Intervention Program
Participants will be yoked (matched) to a participant in the Choice group and they receive the same strategy as the person with a choice.
Behavioral: Nutrition and Exercise Lifestyle Intervention Program
Nutrition and Exercise components for pregnancy
Also known as: NELIP
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).
Time frame: Measured once per week from baseline (12-18 weeks gestation) to end of the intervention (34-36 weeks gestation)
Participant satisfaction
Satisfaction Survey assessed on a 5-point Likert scale; ranging from 1 for very unsatisfied to 5 for very satisfied.
Time frame: 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
Time frame: Measured weekly from 12-18 weeks of pregnancy to 34-36 weeks of pregnancy
Birth weight
Birth weight (measured in kg)
Time frame: Measured within 6 to 18 hours after delivery
Birth length
Birth Length (measured in cms)
Time frame: Measured within 6 to 18 hours after delivery
Birth circumferences
Newborn circumferences (arm, forearm, thigh, leg, abdomen, chest, and head - measured in cm)
Time frame: Measured within 6 to 18 hours after delivery
Birth skinfolds
Newborn skinfolds (biceps, triceps, subscapular, suprailiac, anterior thigh - measured in mm)
Time frame: Measured within 6 to 18 hours after delivery
Pregnancy outcome
APGAR scores (measured out of 10 at 1 minutes and 5 minutes after birth)
Time frame: Measured within 6 to 18 hours after delivery
Pregnancy complications
Pregnancy complications (recorded)
Time frame: Measured within 6 to 18 hours after delivery
Postpartum body weight
Participant body weight (measured in kg)
Time frame: 2, 6 and 12 months after birth
Follow-up Infant weight
Infant weight (measured in kg)
Time frame: 2, 6 and 12 months after birth
Follow-up Infant length
Infant length (measured in cm)
Time frame: 2, 6 and 12 months after birth
Follow-up Infant Girths
Infant circumferences (arm, forearm, thigh, leg, abdomen, chest, head - measured in cm)
Time frame: 2, 6 and 12 months after birth
Follow-up Infant adiposity
Infant skinfold measurements (biceps, triceps, subscapular, suprailiac, anterior thigh - measured in mm)
Time frame: 2, 6 and 12 months after birth
Plan to share: Yes — deidentified data may be shared after publication
Supporting information: Study protocol
Time frame: After completion of the study and after publication
Access criteria: Access with be determined by the principal investigator once the reasons for data acquisition are given
Started Jan 2024 (actual). Primary completion is estimated for Dec 2028, 59 months after the start.
Of 179 non-industry interventional studies with no phase under Treatment Adherence and Compliance, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 59 months is above that.
Counting every sponsor, half of 184 studies reached it within 17 months; a quarter within 9 and three quarters within 36.
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