Infant Peer Interaction Study by Examining the Effect of a 6-week Music Enhancement Program
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      The overall purpose of this study is to better understand food reinforcement in infants. The
      results of this study should help to further our understanding of how individuals relate to
      food and how an enriched environment can change this behavior.
    

Detailed description: 
      The study will be a between subject design with a Music Together intervention group and a
      play date active control group. All subjects will complete the orientation and pre-screening
      intervention assessment sessions.

      All infant-mother dyads in the Music together group will attend a 6 weekly, 45-minute classes
      as a group. Infant-mother dyads will also receive an illustrated songbook with family
      activities to practice and enjoy at home along with the CD. The program provides CD with a
      collection of songs, rhythm chants, "play-alongs", tonal and rhythm patterns, which will be
      used in classes.

      All infant-mother dyads in the play date control group will attend 6 weekly, 45-minute
      organized play dates as a group. These play dates will be planned and led by DBM research
      staff members. Variety of age-appropriate toys (i.e. puzzles, shape sorters, books) will be
      provided for the play date. Each family in the play date group will receive a toy from us to
      practice and play at home with their baby.

      Families in both groups are asked to report their home practice with the song or toy with
      their babies by filling out the Daily Home Practice Survey.

      Both groups will attend a post-intervention training assessment session at the conclusion of
      the 6 week intervention period.

        1. Initial email or phone screen:

           Upon receiving an inquiry from a prospective participant, the study will be explained.
           If the prospective participant has an infant age 9 to 15 months, and she is interested
           in joining the study, a verbal consent will be obtained in order to screen for
           eligibility criteria. The initial screening questionnaire could be done via phone or
           online via Survey Monkey (see Initial Phone Screen/Survey Monkey Questionnaire for
           details). The information assessed during the initial screen is recorded in a secure
           database that requires a password. The database is used by select members of the
           Division of Behavioral Medicine and has been approved for use by previous IRB
           committees.

        2. Orientation:

           If families meet the initial criteria gathered from the initial screen, qualified
           families will be scheduled for an orientation. At the orientation, there will be an
           overview of the study. If interested, parents will be asked to review and sign consent
           forms. Two copies of the consent forms will be signed by all parties involved, person
           obtaining consent, and the participating parent. One copy will be obtained by the study
           personnel and one copy will be given to the participants for their records. The copy
           obtained by study personnel will be kept in a locked cabinet. After signing the consent
           form, the height and weight of the mother and infant will be measured. She will also be
           sent a list of links of questionnaires to be completed at home before the further
           screening/pre-intervention assessment. These questionnaires include the Demographic
           Questionnaire, Pregnancy History and Infant Feeding Practice Questionnaire, Food
           Security Questionnaire, Infant Behavior Questionnaires-Revised (IBQ-R), and Baby Eating
           Behavior Questionnaire (BEBQ). Lastly, before dyads leave, the parent will be asked to
           list three of their child's favorite foods and rank them on a 7 point Likert type scale
           anchored by "Do not Like" to "Like very much". Mother will then be asked to provide the
           child's highest ranked favorite food for the further screening/pre-intervention
           assessment visit.

        3. Further Screening/Pre-Intervention Assessment:

           After orientation, eligible participants will be scheduled for a 45 minute further
           screening/pre-intervention assessment session. For this visit, the mother will be
           advised to choose a time of the day when the infant is generally alert, active and ready
           to play. The infant needs to be fed one hour prior to the lab visit. The mother will be
           reminded to bring diapers or change of clothes for the infant. The mother will also be
           reminded not to feed her infant the test food (infant's favorite food) 24 hours before
           the laboratory visit.

           Then, the mother and infant will be escorted to a laboratory room where the food
           reinforcement game will take place. Infant will be securely fastened on a high chair.
           The mother will be in the room with the infant at all-time during the game. The mother
           will be reminded that the entire reinforcement task procedure will be video recorded to
           obtain vocalization, body movement and facial expression of the infant. The baseline
           state of the infant will be assessed. There are five states: 1 = drowsy, 2 = alert/calm,
           3 = alert/active, 4 = fussy, 5 = crying. Before the start of the game, a study staff
           member will go through a training session with the infant to familiarize him/her with
           the computer based game and button/monitor interface. Mother will be asked to assist
           with the training by repeating phrases the researchers use during the game. After the
           training, the study staff member will start the actual game followed by infant's
           anthropometric measurements.

           After completing all measures, families will be further assessed for eligibility
           criteria. Eligible participants will be randomly assigned to one of two groups; Music
           Together program treatment group or the play date control group. Potential participants
           who are not eligible for the study will be compensated for their time and effort to
           attend the orientation and further screening/pre-intervention assessment.

        4. Intervention The 6-week music intervention, the Music Together® program, was designed in
           collaboration with a local music studio, Betty's Music Together. This program introduced
           infants to the pleasures of music making with their parents rather than passively
           receiving it from CDs or TV. This program provided a rich variety of music and playful
           activities, which encouraged infants and parents to participate at their own level in
           singing, moving, listening, or exploring musical instruments. Participating parents and
           infants attended weekly, 45-minute classes as a group on 6 consecutive Saturday
           mornings. Besides attending classes, parents were encouraged to listen and sing together
           with their infants at home during everyday home activities such as bath time, meal time
           and bed time using the CD and instructional song book provided by the program.

           The active control group consisted of a weekly, 45-minute play date held on the same 6
           consecutive Saturday mornings as the music group. Investigators provided a variety of
           age appropriate toys (no musical toys) and books for participating parents and infants
           to play with and enjoy. Families in the play date group received a toy, Baby's First
           Blocks (Fisher-Price®, East Aurora, NY), to practice and play at home.

           Parents in both groups were advised to attend all classes, with an opportunity to attend
           one makeup session. To encourage families to listen to the Music Together® songs or to
           play with the Baby's First Blocks daily, investigators sent each family a text reminder
           every morning Sunday through Friday for the duration of the intervention. Investigators
           also sent an email Sunday through Friday evenings to remind them to fill out the daily
           home practice survey. Families that filled out at least five of the daily home practice
           surveys and attended that week class or play date were entered into a drawing for a $5
           gift card to a local grocery or coffee shop.

        5. Post-intervention Assessment:

      The post-treatment appointment will follow the same structure and timing as the pre-treatment
      session with the same measurements. Upon completion of all the measures, families will sign
      their payment form and receive a debriefing sheet.

      Further Screening/Pre-Intervention Assessment:

      After the orientation, if participant is eligible investigators will schedule a 30 minute
      visit of further screening/pre-intervention assessment session with participant where
      participant's baby will perform the second part of the reinforcing game.

      Intervention:

      After this assessment, if infant-mother dyads are eligible infant-mother dyads will be
      randomly assigned to Music Together or play date group.

        1. Music Together group This program provides CD with a collection of songs, rhythm chants,
           "play-alongs", tonal and rhythm patterns, which will be used in classes. All
           infant-mother dyads will attend this 6 weekly, 45-minute classes as a group.
           Participants will also receive illustrated songbook with family activities to practice
           and enjoy at home along with the CD.

        2. Play date group These play dates will be planned and led by DBM research staff members,
           which all infant-mother dyads will attend 6 weekly, 45-minute organized play dates as a
           group. Variety of age-appropriate toys (i.e. puzzles, shape sorters, books) will be
           provided for the play date. Participants will also receive a toy from us that
           participants will take home and use to practice and play with participant's baby.

      During the six-week intervention, participants will be asked to fill out a Daily Home
      Practice Survey each day for six days of the week (not on the day participant come for the
      group meeting).

      Post-Intervention Assessment:

      At the end of the 6 week intervention infant-mother dyads will come back into the lab for a
      post-test assessment (2 visits). Infant-mother dyads' height and weight will be measured and
      payment will be given.
    

Intervention name(s): Music
Intervention type(s): Behavioral
Intervention description(s): Music class was provided for the intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment