A Nutrition and Exercise Lifestyle Intervention Program Participant Choice Approach

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestern University, Canada

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

inability to walk

serious medical problems

high blood pressure

uncontrolled chest pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutrition and Exercise Lifestyle Intervention Program

    Behavioral

    Nutrition and Exercise components for pregnancy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ChoiceActive comparator 1 intervention
Group B: No choiceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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
3

Birth weight

Birth weight (measured in kg)

Time frame
Measured within 6 to 18 hours after delivery
4

Birth length

Birth Length (measured in cms)

Time frame
Measured within 6 to 18 hours after delivery

Other outcomes

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